- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02411500
A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males
17 november 2015 uppdaterad av: Trevena Inc.
A Randomized, Open Label, Four Period, Cross-Over Study to Evaluate the Pharmacokinetics of Single Doses of Various TRV734 Formulations in Healthy Male Subjects
The primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
18
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Texas
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San Antonio, Texas, Förenta staterna, 78209
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
- Healthy as determined by a responsible physician or trained qualified designee
- Males: 18 - 55 years inclusive at screening
- Capable of giving written informed consent
Exclusion Criteria:
- Clinically significant conditions or history of fainting or syncope
- Medical or psychiatric illness that could interfere with the completion of treatment and follow up
- Major surgery within 4-weeks of screening
- Known difficulty with obtaining intravenous access
- History of sensitivity to the study medication, or intolerance to opioids, or a history of medication or other allergy that contraindicates their participation
- Use of prescription or non-prescription medications
- History of excessive alcohol use
- History of drug abuse within 6 months of screening
- Use of any illegal drug within 30 days of screening and throughout participation in the study
- History of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study
- Donation of blood or plasma 4 weeks prior to dosing
- Participation in a clinical trial and has received medication within 30 days
- Weight <50 kg or BMI outside range of 18-32 kg/m2
- Positive for HIV antibody, hepatitis B virus surface antigen, or hepatitis C virus
- Unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of child-bearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Formulering A
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Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion.
Days 2, 4, 6 and 8 are designated as washout days.
|
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Experimentell: Formulering B
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Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion.
Days 2, 4, 6 and 8 are designated as washout days.
|
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Experimentell: Formulering C
|
Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion.
Days 2, 4, 6 and 8 are designated as washout days.
|
|
Experimentell: Formulering D
|
Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion.
Days 2, 4, 6 and 8 are designated as washout days.
|
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Experimentell: Formulering e
|
Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion.
Days 2, 4, 6 and 8 are designated as washout days.
|
|
Experimentell: Formulering f
|
Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion.
Days 2, 4, 6 and 8 are designated as washout days.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Evaluate the maximum observed plasma concentration (Cmax)
Tidsram: 9-days
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9-days
|
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Evaluate the time at which the maximum plasma concentration was observed (tmax)
Tidsram: 9-days
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9-days
|
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Evaluate the area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-t)
Tidsram: 9-days
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9-days
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Evaluate the area under the plasma concentration-time curve from time 0 to time extrapolated to infinity (AUC0-inf)
Tidsram: 9-days
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9-days
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Evaluate the apparent elimination half-life (t1/2)
Tidsram: 9-days
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9-days
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Evaluate the apparent clearance (CL/F)
Tidsram: 9-days
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9-days
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Safety and tolerability as measured by adverse events
Tidsram: 9-days
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9-days
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Safety and tolerability as measured by clinical observations
Tidsram: 9-days
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9-days
|
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Safety and tolerability as measured by 12-lead ECGs
Tidsram: 9-days
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9-days
|
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Safety and tolerability as measured by cardiac telemetry monitoring
Tidsram: 9-days
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9-days
|
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Safety and tolerability as measured by vital signs (BP, HR, RR and oral temperature)
Tidsram: 9-days
|
9-days
|
|
Safety and tolerability as measured by oxygen saturation
Tidsram: 9-days
|
9-days
|
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Safety and tolerability as measured by safety laboratory tests
Tidsram: 9-days
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9-days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2015
Primärt slutförande (Faktisk)
1 mars 2015
Avslutad studie (Faktisk)
1 mars 2015
Studieregistreringsdatum
Först inskickad
4 mars 2015
Först inskickad som uppfyllde QC-kriterierna
3 april 2015
Första postat (Uppskatta)
8 april 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
18 november 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 november 2015
Senast verifierad
1 november 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- CP734-1003
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .