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A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males

NCT ID: NCT02411500

Last Updated: 2015-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-03-31

Brief Summary

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The primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Formulation A

Group Type EXPERIMENTAL

TRV734

Intervention Type DRUG

Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.

Formulation B

Group Type EXPERIMENTAL

TRV734

Intervention Type DRUG

Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.

Formulation C

Group Type EXPERIMENTAL

TRV734

Intervention Type DRUG

Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.

Formulation D

Group Type EXPERIMENTAL

TRV734

Intervention Type DRUG

Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.

Formulation E

Group Type EXPERIMENTAL

TRV734

Intervention Type DRUG

Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.

Formulation F

Group Type EXPERIMENTAL

TRV734

Intervention Type DRUG

Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.

Interventions

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TRV734

Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy as determined by a responsible physician or trained qualified designee
* Males: 18 - 55 years inclusive at screening
* Capable of giving written informed consent

Exclusion Criteria

* Clinically significant conditions or history of fainting or syncope
* Medical or psychiatric illness that could interfere with the completion of treatment and follow up
* Major surgery within 4-weeks of screening
* Known difficulty with obtaining intravenous access
* History of sensitivity to the study medication, or intolerance to opioids, or a history of medication or other allergy that contraindicates their participation
* Use of prescription or non-prescription medications
* History of excessive alcohol use
* 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 4 weeks prior to dosing
* Participation in a clinical trial and has received 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
* Unwillingness to abstain from sexual intercourse with a pregnant or lactating woman and, if engaging in sexual intercourse with a female partner of child-bearing potential, use a condom and spermicide, in addition to having their female partner use another form of contraception, and abstain from sperm donation
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Trevena Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CP734-1003

Identifier Type: -

Identifier Source: org_study_id