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

NCT02211625 | Completed Phase 1 DMC

• 1 other identifier: CP734-1002
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; Pharmacodynamics (PD); Pharmacokinetics (PK)

Outcome Measures

Primary Outcomes (1)

• Safety

  Clinical safety data from adverse event reporting, clinical observations, 12-lead ECGs, cardiac telemetry monitoring, vital signs (blood pressure, heart rate, respiratory rate and oral temperature), oxygen saturation and safety laboratory tests.

  7 days

Secondary Outcomes (4)

• Effect on pharmacodynamics of multiple ascending doses (Part B) of TRV734

  4 days

• Effect on pharmacokinetics of multiple ascending (Part B) doses of TRV734

  4 days

• Effect on pharmacodynamics of 125mg dose or TRV734 (Part A) following various administration paradigms

  7 days

• Effect on pharmacokinetics of 125mg dose of TRV734 (Part A) following various administration paradigms.

  7 days

Study Arms (2)

TRV734 125 mg

EXPERIMENTAL

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.

Drug: Open-label TRV734 125 mg

Multiple ascending dose study, active and placebo comparators

ACTIVE COMPARATOR

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.

Drug: TRV734 blinded; Drug: Oxycodone IR 10 mg; Drug: Placebo

Interventions

Open-label TRV734 125 mg DRUG

125 mg

TRV734 125 mg

TRV734 blinded DRUG

blinded, multiple ascending dose

Multiple ascending dose study, active and placebo comparators

Oxycodone IR 10 mg DRUG

Multiple ascending dose study, active and placebo comparators

Placebo DRUG

TRV734-matched and oxycodone placebo

Multiple ascending dose study, active and placebo comparators

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trevena Inc.: lead

Study Sites (1)

ICON Development Solutions

San Antonio, Texas, 78209, United States

Location

Study Officials

• Franck Skobieranda, MD

  Trevena Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 7, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

US (1)