Clinical trial NCT02411500: A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males
Official title: A Randomized, Open Label, Four Period, Cross-Over Study to Evaluate the Pharmacokinetics of Single Doses of Various TRV734 Formulations in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Male
Pharmacokinetics
Lead sponsor: Trevena Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-08
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the maximum observed plasma concentration (Cmax)
timeFrame: 9-days
measure: Evaluate the time at which the maximum plasma concentration was observed (tmax)
timeFrame: 9-days
measure: Evaluate the area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-t)
timeFrame: 9-days
measure: Evaluate the area under the plasma concentration-time curve from time 0 to time extrapolated to infinity (AUC0-inf)
timeFrame: 9-days
measure: Evaluate the apparent elimination half-life (t1/2)
timeFrame: 9-days
measure: Evaluate the apparent clearance (CL/F)
timeFrame: 9-days
Secondary outcomes:
measure: Safety and tolerability as measured by adverse events
timeFrame: 9-days
measure: Safety and tolerability as measured by clinical observations
timeFrame: 9-days
measure: Safety and tolerability as measured by 12-lead ECGs
timeFrame: 9-days
measure: Safety and tolerability as measured by cardiac telemetry monitoring
timeFrame: 9-days
measure: Safety and tolerability as measured by vital signs (BP, HR, RR and oral temperature)
timeFrame: 9-days
measure: Safety and tolerability as measured by oxygen saturation
timeFrame: 9-days
measure: Safety and tolerability as measured by safety laboratory tests
timeFrame: 9-days
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
References: