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

Trevena

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Oxycodone IR 10 mg; Drug: TRV734 blinded; Drug: Open-label TRV734 125 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02211625

CP734-1002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

TRV734 125 mg

Experimental group

Description:

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.

Treatment:

Drug: Open-label TRV734 125 mg

Multiple ascending dose study, active and placebo comparators

Active Comparator group

Description:

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.

Treatment:

Drug: Oxycodone IR 10 mg

Drug: TRV734 blinded

Drug: Placebo