Clinical trial NCT02211625: A Safety, Tolerability, PD and PK Study in Healthy Adults
Official title: A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacodynamics And Pharmacokinetics of TRV734 in Healthy Adult Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Pharmacodynamics (PD)
Pharmacokinetics (PK)
Lead sponsor: Trevena Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety
timeFrame: 7 days
Secondary outcomes:
measure: Effect on pharmacodynamics of multiple ascending doses (Part B) of TRV734
timeFrame: 4 days
measure: Effect on pharmacokinetics of multiple ascending (Part B) doses of TRV734
timeFrame: 4 days
measure: Effect on pharmacodynamics of 125mg dose or TRV734 (Part A) following various administration paradigms
timeFrame: 7 days
measure: Effect on pharmacokinetics of 125mg dose of TRV734 (Part A) following various administration paradigms.
timeFrame: 7 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Development Solutions
state: Texas
Study officials:
affiliation: Trevena Inc.
name: Franck Skobieranda, MD
role: STUDY_DIRECTOR
References: