Recruitment

Recruitment Status
Completed
Estimated Enrollment
72

Inclusion Criterias

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

Exclusion Criterias

Any ophthalmologic condition that could interfere with pupillometry
Participation in a clinical trial and has received a medication within 30 days
Clinically significant conditions, or history of fainting or syncope
...
Any ophthalmologic condition that could interfere with pupillometry
Participation in a clinical trial and has received a medication within 30 days
Clinically significant conditions, or history of fainting or syncope
Use of any illegal drug within 30 days of screening and throughout participation in the study
Peripheral vascular disease
Donation of blood or plasma within 4 weeks prior to dosing
History of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study
History of sensitivity to any of the investigational products, or known intolerance to opioids or a history of medication or other allergy
Major surgery within 4 weeks of screening
Active dermatological condition or eczema on non-dominant hand.
History of drug abuse within 6 months of screening
Use of prescription or non prescription medications
Known difficulty with obtaining intravenous access
If female, of child bearing potential, pregnant or breastfeeding
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
Medical or psychiatric illness
Positive for HIV antibody, hepatitis B virus surface antigen, or hepatitis C virus
Weight <50 kg or BMI outside range of 18 - 32 kg/m2

Summary

Conditions
Healthy
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 64 years
Gender
Both males and females

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-f...

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.

Inclusion Criterias

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

Exclusion Criterias

Any ophthalmologic condition that could interfere with pupillometry
Participation in a clinical trial and has received a medication within 30 days
Clinically significant conditions, or history of fainting or syncope
...
Any ophthalmologic condition that could interfere with pupillometry
Participation in a clinical trial and has received a medication within 30 days
Clinically significant conditions, or history of fainting or syncope
Use of any illegal drug within 30 days of screening and throughout participation in the study
Peripheral vascular disease
Donation of blood or plasma within 4 weeks prior to dosing
History of smoking or use of nicotine containing products within 3 months of screening and throughout participation in the study
History of sensitivity to any of the investigational products, or known intolerance to opioids or a history of medication or other allergy
Major surgery within 4 weeks of screening
Active dermatological condition or eczema on non-dominant hand.
History of drug abuse within 6 months of screening
Use of prescription or non prescription medications
Known difficulty with obtaining intravenous access
If female, of child bearing potential, pregnant or breastfeeding
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
Medical or psychiatric illness
Positive for HIV antibody, hepatitis B virus surface antigen, or hepatitis C virus
Weight <50 kg or BMI outside range of 18 - 32 kg/m2

Locations

San Antonio, Texas, 78209
San Antonio, Texas, 78209

Tracking Information

NCT #
NCT02211625
Collaborators
Not Provided
Investigators
Study Director: Franck Skobieranda, MD Trevena Inc.