A Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG) (MK-1064-003)
24. september 2018 oppdatert av: Merck Sharp & Dohme LLC
A Crossover Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG)
The purpose of this randomized, double-blind, placebo-controlled, 5-period crossover study is to assess the effect of single oral doses of MK-1064 on latency to persistent sleep (LPS) as measured by polysomnography (PSG) in healthy young male participants, and to evaluate the safety and tolerability of single oral doses of MK-1064 and MK-6096 in healthy young male participants.
The primary efficacy hypothesis is that at least one dose of MK-1064 is superior to placebo in decreasing LPS in healthy male participants as assessed by PSG.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Fase 1
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 45 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Body Mass Index (BMI) ≤31 kg/m^2
- In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
- Nonsmoker and has not used nicotine or nicotine-containing products for at least 6 months
- No history of any sleep disorder
- Has not used prescription or over the counter sedation or alerting medication in 4 weeks prior to screening
- Participant has a usual bedtime between 8:00 PM and 12:00 AM
- Participant has total sleep duration of ≥6.5 and ≤9 hours during the 4 weeks prior to screening
- Male participants with female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
Exclusion Criteria:
- Mentally or legally incapacitated, significant emotional problems at screening or expected during the conduct of the study or history of a clinically significant psychiatric disorder within the last 10 years
- History of any persistent sleep abnormality (including difficulty falling asleep, difficulty staying asleep) lasting for 3 months or more, or history of obstructive sleep apnea, restless leg syndrome, or narcolepsy
- History of clinically significant sleep disorders within the last 5 years
- History of circadian rhythm sleep disorder, clinically important parasomnia, or primary insomnia
- History of repeated falls or fractures secondary to falling within the past 2 years
- Participant works a night shift and is not able to avoid night shift work a minimum of 1 week prior to screening and for the duration of the study
- Participant has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study
- Is a regular user of sedative-hypnotic agents
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- History of stroke, peripheral neuropathy, chronic seizures or other clinically significant neurological disorder or cognitive impairment
- History of cancer
- History of cataplexy
- Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies, beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study
- Participant consumes >3 servings of alcohol a day
- Participant consumes >6 caffeine servings a day
- Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to screening, or participated in another investigational study within 3 months prior to first dose of study drug
- History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- Is currently a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within 2 years of screening
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg
For overall study population, 5 participants each were to be allocated to one of 4 sequences.
In this sequence, participants received the following: Period 1 - single dose of 50 mg MK-1064, Period 2 - single dose of 250 mg MK-1064, Period 3 - single dose of placebo, Period 4 - single dose of 120 mg MK-1064.
Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation.
There was a minimum 7-day washout between doses.
|
Oral MK-1064 tablets (10 and 50 mg strengths)
Oral MK-6096 tablets (5 mg strength)
Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)
|
|
Eksperimentell: Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg
For overall study population, 5 participants each were to be allocated to one of 4 sequences.
In this sequence, participants received the following: Period 1 - single dose of placebo, Period 2 - single dose of 50 mg MK-1064, Period 3 - single dose of 120 mg MK-1064, Period 4 - single dose of 250 mg MK-1064.
Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation.
There was a minimum 7-day washout between doses.
|
Oral MK-1064 tablets (10 and 50 mg strengths)
Oral MK-6096 tablets (5 mg strength)
Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)
|
|
Eksperimentell: Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg
For overall study population, 5 participants each were to be allocated to one of 4 sequences.
In this sequence, participants received the following: Period 1 - single dose of 120 mg MK-1064, Period 2 - single dose of placebo, Period 3 - single dose of 250 mg MK-1064, Period 4 - single dose of 50 mg MK-1064.
Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation.
There was a minimum 7-day washout between doses.
|
Oral MK-1064 tablets (10 and 50 mg strengths)
Oral MK-6096 tablets (5 mg strength)
Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)
|
|
Eksperimentell: Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo
For overall study population, 5 participants each were to be allocated to one of 4 sequences.
In this sequence, participants received the following: Period 1 - single dose of 250 mg MK-1064, Period 2 - single dose of 120 mg MK-1064, Period 3 - single dose of 50 mg MK-1064, Period 4 - single dose of placebo.
Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation.
There was a minimum 7-day washout between doses.
|
Oral MK-1064 tablets (10 and 50 mg strengths)
Oral MK-6096 tablets (5 mg strength)
Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo
Tidsramme: 1 to 9 hours post dose, within each treatment period
|
LPS is measured during overnight sleep laboratory (polysomnography [PSG]) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.
|
1 to 9 hours post dose, within each treatment period
|
|
LPS Following Single Doses of MK-6096 and Placebo
Tidsramme: 1 to 9 hours post dose, within each treatment period
|
LPS is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.
|
1 to 9 hours post dose, within each treatment period
|
|
Number of Participants With Adverse Events (AEs)
Tidsramme: Up to 14 days after the last dose of study drug (Up to approximately 42 days)
|
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.
|
Up to 14 days after the last dose of study drug (Up to approximately 42 days)
|
|
Number of Participants Who Discontinued Study Due to an AE
Tidsramme: Up to 14 days after the last dose of study drug (Up to approximately 42 days)
|
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.
|
Up to 14 days after the last dose of study drug (Up to approximately 42 days)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Wake Time After Sleep Onset (WASO) Following Single Doses of MK-1064 and Placebo
Tidsramme: 1 to 9 hours post dose, within each treatment period
|
WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.
|
1 to 9 hours post dose, within each treatment period
|
|
WASO Following Single Doses of MK-6096 and Placebo
Tidsramme: 1 to 9 hours post dose, within each treatment period
|
WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.
|
1 to 9 hours post dose, within each treatment period
|
|
Change From Baseline in Choice Reaction Time (CRT) Following Single Doses of MK-1064 and Placebo
Tidsramme: Pre-dose and 10 hours post dose, within each treatment period
|
CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer.
During the test either the word "NO" or the word "YES" is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible.
There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval.
The mean reaction time of accurate responses is determined.
The assessment is performed pre-dose and at 10 hours post dose.
The outcome measure is change from baseline to post dose in reaction time.
|
Pre-dose and 10 hours post dose, within each treatment period
|
|
Change From Baseline in CRT Following Single Doses of MK-6096 and Placebo
Tidsramme: Pre-dose and 10 hours post dose, within each treatment period
|
CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer.
During the test either the word "NO" or the word "YES" is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible.
There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval.
The mean reaction time of accurate responses is determined.
The assessment is performed pre-dose and at 10 hours post dose.
The outcome measure is change from baseline to post dose in reaction time.
|
Pre-dose and 10 hours post dose, within each treatment period
|
Samarbeidspartnere og etterforskere
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Sponsor
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 (Faktiske)
6. november 2009
Primær fullføring (Faktiske)
6. april 2010
Studiet fullført (Faktiske)
6. april 2010
Datoer for studieregistrering
Først innsendt
11. september 2015
Først innsendt som oppfylte QC-kriteriene
11. september 2015
Først lagt ut (Anslag)
14. september 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. oktober 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. september 2018
Sist bekreftet
1. september 2018
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 1064-003
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ja
IPD-planbeskrivelse
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Studiedata/dokumenter
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. .