A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males

NCT02411500 | Completed Phase 1

• 1 other identifier: CP734-1003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy; Male; Pharmacokinetics

Outcome Measures

Primary Outcomes (6)

• Evaluate the maximum observed plasma concentration (Cmax)

  9-days

• Evaluate the time at which the maximum plasma concentration was observed (tmax)

  9-days

• Evaluate the area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-t)

  9-days

• Evaluate the area under the plasma concentration-time curve from time 0 to time extrapolated to infinity (AUC0-inf)

  9-days

• Evaluate the apparent elimination half-life (t1/2)

  9-days

• Evaluate the apparent clearance (CL/F)

  9-days

Secondary Outcomes (7)

• Safety and tolerability as measured by adverse events

  9-days

• Safety and tolerability as measured by clinical observations

  9-days

• Safety and tolerability as measured by 12-lead ECGs

  9-days

• Safety and tolerability as measured by cardiac telemetry monitoring

  9-days

• Safety and tolerability as measured by vital signs (BP, HR, RR and oral temperature)

  9-days

Study Arms (6)

Formulation A

EXPERIMENTAL

Drug: TRV734

Formulation B

EXPERIMENTAL

Drug: TRV734

Formulation C

EXPERIMENTAL

Drug: TRV734

Formulation D

EXPERIMENTAL

Drug: TRV734

Formulation E

EXPERIMENTAL

Drug: TRV734

Formulation F

EXPERIMENTAL

Drug: TRV734

Interventions

TRV734 DRUG

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.

Formulation A; Formulation B; Formulation C; Formulation D; Formulation E; Formulation F

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy as determined by a responsible physician or trained qualified designee
• Males: 18 - 55 years inclusive at screening
• Capable of giving written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Trevena Inc.: lead

Study Sites (1)

Unknown Facility

San Antonio, Texas, 78209, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: April 8, 2015
• Study Start: February 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

US (1)