- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02211625
A Safety, Tolerability, PD and PK Study in Healthy Adults
December 4, 2014 updated by: Trevena Inc.
A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacodynamics And Pharmacokinetics of TRV734 in Healthy Adult Male and Female Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78209
- ICON Development Solutions
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TRV734 125 mg
Part A, open-label will evaluate the the safety, PK and PD profile of a 125mg dose of TRV734 in which subjects are fasted, fed a standard meal, or fed a high-fat meal.
Part A will also inform the dosing paradigm for Part B.
|
125 mg
|
Active Comparator: Multiple ascending dose study, active and placebo comparators
Part B will assess the safety, tolerability, PD and PK of TRV734.
Subjects will be randomized in a ratio of 3:1:1 to receive either multiple doses of TRV734, oxycodone IR 10mg or placebo.
|
blinded, multiple ascending dose
TRV734-matched and oxycodone placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 7 days
|
Clinical safety data from adverse event reporting, clinical observations, 12-lead ECGs, cardiac telemetry monitoring, vital signs (blood pressure, heart rate, respiratory rate and oral temperature), oxygen saturation and safety laboratory tests.
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect on pharmacodynamics of multiple ascending doses (Part B) of TRV734
Time Frame: 4 days
|
Change from baseline in: Pupillometry and Cold Pain Test
|
4 days
|
Effect on pharmacokinetics of multiple ascending (Part B) doses of TRV734
Time Frame: 4 days
|
From the plasma concentration-time data, the following PK parameters will be determined, as data permit: AUC, Cmax, tmax, t½,eff, Vss/F, C, AR, and CL/F.
From the urine concentration data, the following will PK parameters will be determined, as data permit: %UR and CLR.
|
4 days
|
Effect on pharmacodynamics of 125mg dose or TRV734 (Part A) following various administration paradigms
Time Frame: 7 days
|
Change from baseline in: Pupillometry and Cold Pain Test
|
7 days
|
Effect on pharmacokinetics of 125mg dose of TRV734 (Part A) following various administration paradigms.
Time Frame: 7 days
|
From the plasma concentration-time data, the following PK parameters will be determined, as data permit: AUC, Cmax, tmax, t½,eff, Vss/F, C, AR, and CL/F.
From the urine concentration data, the following will PK parameters will be determined, as data permit: %UR and CLR.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
July 29, 2014
First Submitted That Met QC Criteria
August 5, 2014
First Posted (Estimate)
August 7, 2014
Study Record Updates
Last Update Posted (Estimate)
December 5, 2014
Last Update Submitted That Met QC Criteria
December 4, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP734-1002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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