- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01775189
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted
17. april 2017 oppdatert av: Pfizer
A Randomized, Double-blind, Placebo Controlled, Single-dose, 4-way Crossover Study To Determine The Relative Abuse Potential Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended Release Capsules) Compared To Oxycodone Immediate Release, And Placebo When Administered Intranasally To Non-dependent, Recreational Opioid Users.
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused when they are crushed and snorted.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Abuse Liability Study
Studietype
Intervensjonell
Registrering (Faktiske)
45
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5V 2T3
- INC Research Toronto Inc.
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy subjects
- Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year and at least once in the 8 weeks before Visit 1 (Screening Visit).
- Must have experience with intranasal opioid administration (snorted opioid drugs on at least 3 occassions within the last year before Visit 1 (Screening Visit).
Exclusion Criteria:
- Diagnosis of substance and/or alcohol dependence
- Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Behandling B
|
crushed ALO-02 30 mg/3.6 mg capsule x 1 dose
|
Placebo komparator: Behandling C
|
crushed lactose tablets (powder) x 1 dose
|
Aktiv komparator: Behandling D
|
Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose
|
Placebo komparator: Behandling A
|
crushed sugar spheres (powder) x 1 dose
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Drug Liking: Peak Effect (Emax)
Tidsramme: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment).
It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm).
Peak Effect (Emax) = Maximum observed score.
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour
Tidsramme: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment).
It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm).
AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
High: Peak Effect (Emax)
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
High: Area Under Effect Curve (AUE) From 0-2 Hour
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Take Drug Again: Peak Effect (Emax)
Tidsramme: Intervention period: 12, 24 hours post-dose
|
Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity.
It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would").
Emax = Maximum observed score.
|
Intervention period: 12, 24 hours post-dose
|
Take Drug Again: Mean Effect (Emean)
Tidsramme: Intervention period: 12, 24 hours post-dose
|
Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity.
It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would").
Emean = Average observed score.
|
Intervention period: 12, 24 hours post-dose
|
Take Drug Again Effect at Hours 12 and 24
Tidsramme: Intervention period: 12, 24 hours post-dose
|
Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity.
It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would").
|
Intervention period: 12, 24 hours post-dose
|
Overall Drug Liking: Peak Effect (Emax)
Tidsramme: Intervention period: 12, 24 hours post-dose
|
Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects).
A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm = "neither like nor dislike", and 100 mm= "strong liking").
Emax = Maximum observed score.
|
Intervention period: 12, 24 hours post-dose
|
Overall Drug Liking: Mean Effect (Emean)
Tidsramme: Intervention period: 12, 24 hours post-dose
|
Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects).
A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm = "neither like nor dislike", and 100 mm= "strong liking").
Emean = Average observed score.
|
Intervention period: 12, 24 hours post-dose
|
Overall Drug Liking Effect at Hours 12 and 24
Tidsramme: Intervention period: 12, 24 hours post-dose
|
Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects).
A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm = "neither like nor dislike", and 100 mm= "strong liking").
|
Intervention period: 12, 24 hours post-dose
|
Any Drug Effects: Peak Effect (Emax)
Tidsramme: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Tidsramme: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)
Tidsramme: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Good Drug Effects: Peak Effect (Emax)
Tidsramme: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Tidsramme: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)
Tidsramme: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Bad Drug Effects: Peak Effect (Emax)
Tidsramme: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Tidsramme: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)
Tidsramme: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Feel Sick: Peak Effect (Emax)
Tidsramme: Intervention periods: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
|
Intervention periods: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Feel Sick: Time to Maximum (Peak) Effect (TEmax)
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Nausea: Peak Effect (Emax)
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Nausea: Time to Maximum (Peak) Effect (TEmax)
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Sleepy: Peak Effect (Emax)
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Sleepy: Time to Maximum (Peak) Effect (TEmax)
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Dizzy: Peak Effect (Emax)
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Dizzy: Time to Maximum (Peak) Effect (TEmax)
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Percentage of Dose (Drug Powder) Insufflated
Tidsramme: Intervention period: 0 Hour post-dose
|
The percentage of dose insufflated, was based on a calculation of the weight of powder remaining (if any) following each dosing during the intervention period.
|
Intervention period: 0 Hour post-dose
|
Pupillometry: Peak Effect (Emax)
Tidsramme: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties.
Participants have the size of pupil measured using a pupillometer.
Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions.
The same eye for each participant was used for all measurements during the study.
Emax = Maximum observed score.
|
Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
Tidsramme: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties.
Participants have the size of pupil measured using a pupillometer.
Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions.
The same eye for each participant was used for all measurements during the study.
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
|
Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Pupillometry: Time to Maximum (Peak) Effect (TEmax)
Tidsramme: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties.
Participants have the size of pupil measured using a pupillometer.
Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions.
The same eye for each participant was used for all measurements during the study.
TEmax = Time to maximum observed score.
|
Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour
Tidsramme: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment).
It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Drug Liking: Time to Maximum (Peak) Effect (TEmax)
Tidsramme: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment).
It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm).
TEmax = Time to maximum observed score.
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
High: Time to Maximum (Peak) Effect (TEmax)
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Subject Rating Scale for Nasal Effects: Peak Effect (Emax)
Tidsramme: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem "as bad as can be").
Emax = Maximum observed score.
|
Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour
Tidsramme: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem "as bad as can be").
AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).
|
Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax)
Tidsramme: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem "as bad as can be").
TEmax = Time to maximum observed score.
|
Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Participants who received oxycodone and ALO-02 were reported.
Oxymorphone and noroxycodone are metabolites of oxycodone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Participants who received ALO-02 were reported.
6-Beta-naltrexol is metabolites of naltrexone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Participants who received oxycodone and ALO-02 were reported.
Oxymorphone and noroxycodone are metabolites of oxycodone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Participants who received ALO-02 were reported.
6-Beta-naltrexol is metabolites of naltrexone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Participants who received oxycodone and ALO-02 were reported.
Oxymorphone and noroxycodone are metabolites of oxycodone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Plasma Decay Half-Life (t1/2) of Naltrexone and 6-beta-naltrexol
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Participants who received ALO-02 were reported.
6-Beta-naltrexol is metabolites of naltrexone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose
|
AUC is a measure of the serum concentration of the drug over time.
It is used to characterize drug absorption.
Participants who received oxycodone and ALO-02 were reported.
Oxymorphone and noroxycodone are metabolites of oxycodone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast).
Participants who received oxycodone and ALO-02 were reported.
Oxymorphone and noroxycodone are metabolites of oxycodone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
It is obtained from AUC (0 - t) plus AUC (t - ∞).
Participants who received oxycodone and ALO-02 were reported.
Oxymorphone and noroxycodone are metabolites of oxycodone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose
|
AUC is a measure of the serum concentration of the drug over time.
It is used to characterize drug absorption.
Participants who received ALO-02 were reported.
6-Beta-naltrexol is metabolites of naltrexone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Naltrexone and 6-beta-naltrexol
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast).
Participants who received ALO-02 were reported.
6-Beta-naltrexol is metabolites of naltrexone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone and 6-beta-naltrexol
Tidsramme: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
It is obtained from AUC (0 - t) plus AUC (t - ∞).
Participants who received ALO-02 were reported.
6-Beta-naltrexol is metabolites of naltrexone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Tidsramme: Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal
|
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship.
SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 3 - 7 days following last study drug administration that were absent before treatment or that worsened relative to pre-treatment state.
Symptoms of withdrawal following naloxone administration (naloxone challenge phase) were not collected as adverse events unless they met the criteria for an SAE.
AEs included SAEs as well as non-serious AEs which occurred during the trial.
|
Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal
|
Number of Participants With Clinically Significant Change in Vital Sign Examinations
Tidsramme: Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal
|
Vital signs assessment included measurement of heart rate, systolic and diastolic blood pressures, and respiratory rate.
Criteria for clinically significant change in any vital sign examination was based on investigator's discretion.
|
Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal
|
Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)
Tidsramme: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
End-tidal carbon dioxide concentration in the expired air (EtCO2) was monitored using capnography in a sitting position.
Criteria for clinically significant change in EtCO2 was based on investigator's discretion.
|
Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2)
Tidsramme: Drug discrimination phase: pre-dose up to 5 hours; intervention period: pre-dose up to 12 hours
|
Oxygen saturation of hemoglobin in blood (SpO2) was monitored using pulse oximetry continuously for 5 hours following dosing in the drug discrimination phase and continuously for 12 hours following dosing in the treatment phase, or longer at the discretion of the investigator.
Individual measurement was collected in a sitting position.
If SpO2 fall below 90 percent (%), the investigator administered oxygen via nasal cannula at a flow rate sufficient to maintain the SpO2 greater than or equal to 90%.
Participants with fall in SpO2 below 90% were reported.
|
Drug discrimination phase: pre-dose up to 5 hours; intervention period: pre-dose up to 12 hours
|
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2013
Primær fullføring (Faktiske)
1. juli 2013
Studiet fullført (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først innsendt
22. januar 2013
Først innsendt som oppfylte QC-kriteriene
22. januar 2013
Først lagt ut (Anslag)
24. januar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. juli 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. april 2017
Sist bekreftet
1. februar 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B4531009
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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