Recruitment

Recruitment Status
Completed
Estimated Enrollment
72

Inclusion Criteria

Capable of giving written informed consent
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
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

Exclusion Criteria

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

Summary

Conditions
  • Healthy
  • test @ # $ % 123 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 Criteria

Capable of giving written informed consent
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
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

Exclusion Criteria

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

Locations

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

Tracking Information

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