A Safety, Tolerability, PD and PK Study in Healthy Adults
Last updated on October 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 72
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
- 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
- Weight <50 kg or BMI outside range of 18 - 32 kg/m2
- Any ophthalmologic condition that could interfere with pupillometry
- History of drug abuse within 6 months of screening
- ...
- Weight <50 kg or BMI outside range of 18 - 32 kg/m2
- Any ophthalmologic condition that could interfere with pupillometry
- 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
- Major surgery within 4 weeks of screening
- History of smoking or use of nicotine containing products within 3 months 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
- Participation in a clinical trial and has received a medication within 30 days
- Positive for HIV antibody, hepatitis B virus surface antigen, or hepatitis C virus
- Medical or psychiatric illness
- Known difficulty with obtaining intravenous access
- Active dermatological condition or eczema on non-dominant hand.
- Peripheral vascular disease
- 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
- Donation of blood or plasma within 4 weeks prior to dosing
- 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
- 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
- Capable of giving written informed consent
Exclusion Criteria
- Weight <50 kg or BMI outside range of 18 - 32 kg/m2
- Any ophthalmologic condition that could interfere with pupillometry
- History of drug abuse within 6 months of screening
- ...
- Weight <50 kg or BMI outside range of 18 - 32 kg/m2
- Any ophthalmologic condition that could interfere with pupillometry
- 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
- Major surgery within 4 weeks of screening
- History of smoking or use of nicotine containing products within 3 months 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
- Participation in a clinical trial and has received a medication within 30 days
- Positive for HIV antibody, hepatitis B virus surface antigen, or hepatitis C virus
- Medical or psychiatric illness
- Known difficulty with obtaining intravenous access
- Active dermatological condition or eczema on non-dominant hand.
- Peripheral vascular disease
- 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
- Donation of blood or plasma within 4 weeks prior to dosing
- 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.