Recruitment

Recruitment Status
Completed
Estimated Enrollment
72

Inclusion Criteria

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
Capable of giving written informed consent
Healthy as determined by a responsible physician or trained qualified designee

Exclusion Criteria

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

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

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
Capable of giving written informed consent
Healthy as determined by a responsible physician or trained qualified designee

Exclusion Criteria

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

Locations

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

Tracking Information

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