A Safety, Tolerability, PD and PK Study in Healthy Adults

NCT ID: NCT02211625

Last Updated: 2014-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-10-31

Brief Summary

The primary objective of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of TRV734 given as a single dose (Part A) and as multiple ascending doses (Part B) in healthy subjects.

Detailed Description

This will be conducted in two-parts enrolling a total of approximately 72 healthy volunteers.

• Part A will assess the safety, tolerability, PD and PK of a 125mg dose of TRV734 in an open-label, randomized, three-period crossover study in which subjects are fasted, fed a standard meal, or fed a high-fat meal.
• Part B of the trial will assess the safety, tolerability, PD and PK of multiple ascending doses of TRV734 in a double blind, double dummy, randomized, active- and placebo-controlled, adaptive study. Oxycodone immediate release (IR) 10 mg will be used as a benchmark.

Conditions

Healthy

Keywords

Healthy; Pharmacodynamics (PD); Pharmacokinetics (PK)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TRV734 125 mg

Part A, open-label will evaluate the the safety, PK and PD profile of a 125mg dose of TRV734 in which subjects are fasted, fed a standard meal, or fed a high-fat meal. Part A will also inform the dosing paradigm for Part B.

Group Type: EXPERIMENTAL

Open-label TRV734 125 mg

Intervention Type: DRUG

125 mg

Multiple ascending dose study, active and placebo comparators

Part B will assess the safety, tolerability, PD and PK of TRV734. Subjects will be randomized in a ratio of 3:1:1 to receive either multiple doses of TRV734, oxycodone IR 10mg or placebo.

Group Type: ACTIVE_COMPARATOR

TRV734 blinded

Intervention Type: DRUG

blinded, multiple ascending dose

Oxycodone IR 10 mg

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

TRV734-matched and oxycodone placebo

Interventions

Open-label TRV734 125 mg

125 mg

Intervention Type: DRUG

TRV734 blinded

blinded, multiple ascending dose

Intervention Type: DRUG

Oxycodone IR 10 mg

Intervention Type: DRUG

Placebo

TRV734-matched and oxycodone placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy as determined by a responsible physician or trained qualified designee
• Males (Part A) or males and females (Part B) between 18 & 64 years of age, inclusive. Females must be of non-childbearing
• Capable of giving written informed consent

Exclusion Criteria

• Clinically significant conditions, or history of fainting or syncope
• Medical or psychiatric illness
• Major surgery within 4 weeks of screening
• Known difficulty with obtaining intravenous access
• Any ophthalmologic condition that could interfere with pupillometry
• History of sensitivity to any of the investigational products, or known intolerance to opioids or a history of medication or other allergy
• Use of prescription or non prescription medications
• 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 within 4 weeks prior to dosing
• Participation in a clinical trial and has received a 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
• If male, unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of childbearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation
• Part B Only:

• Active dermatological condition or eczema on non-dominant hand.
• Peripheral vascular disease
• If female, of child bearing potential, pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Trevena Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franck Skobieranda, MD

Role: STUDY_DIRECTOR

Trevena Inc.

Locations

ICON Development Solutions

San Antonio, Texas, United States

Countries

United States

Other Identifiers

CP734-1002

Identifier Type: -

Identifier Source: org_study_id