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A Safety, Tolerability, PD and PK Study in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02211625
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
Trevena Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Open-label TRV734 125 mg Drug: TRV734 blinded Drug: Oxycodone IR 10 mg Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacodynamics And Pharmacokinetics of TRV734 in Healthy Adult Male and Female Subjects
Study Start Date : July 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Oxycodone

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.
Drug: Open-label TRV734 125 mg
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.
Drug: TRV734 blinded
blinded, multiple ascending dose

Drug: Oxycodone IR 10 mg
Drug: Placebo
TRV734-matched and oxycodone placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Effect on pharmacodynamics of multiple ascending doses (Part B) of TRV734 [ Time Frame: 4 days ]
    Change from baseline in: Pupillometry and Cold Pain Test

  2. 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.

  3. 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

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02211625


Locations
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United States, Texas
ICON Development Solutions
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Trevena Inc.
Investigators
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Study Director: Franck Skobieranda, MD Trevena Inc.
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Responsible Party: Trevena Inc.
ClinicalTrials.gov Identifier: NCT02211625    
Other Study ID Numbers: CP734-1002
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by Trevena Inc.:
Healthy
Pharmacodynamics (PD)
Pharmacokinetics (PK)
Additional relevant MeSH terms:
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Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents