A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult Males

Study Overview
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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.

Official Title
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A Randomized, Open Label, Four Period, Cross-Over Study to Evaluate the Pharmacokinetics of Single Doses of Various TRV734 Formulations in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: TRV734


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation A<br> | Drug: TRV734<br>* 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.<br>|
| Experimental: Formulation B<br> | Drug: TRV734<br>* 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.<br>|
| Experimental: Formulation C<br> | Drug: TRV734<br>* 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.<br>|
| Experimental: Formulation D<br> | Drug: TRV734<br>* 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.<br>|
| Experimental: Formulation E<br> | Drug: TRV734<br>* 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.<br>|
| Experimental: Formulation F<br> | Drug: TRV734<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the maximum observed plasma concentration (Cmax) |  | 9-days | 
| Evaluate the time at which the maximum plasma concentration was observed (tmax) |  | 9-days | 
| Evaluate the area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-t) |  | 9-days | 
| Evaluate the area under the plasma concentration-time curve from time 0 to time extrapolated to infinity (AUC0-inf) |  | 9-days | 
| Evaluate the apparent elimination half-life (t1/2) |  | 9-days | 
| Evaluate the apparent clearance (CL/F) |  | 9-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as measured by adverse events |  | 9-days | 
| Safety and tolerability as measured by clinical observations |  | 9-days | 
| Safety and tolerability as measured by 12-lead ECGs |  | 9-days | 
| Safety and tolerability as measured by cardiac telemetry monitoring |  | 9-days | 
| Safety and tolerability as measured by vital signs (BP, HR, RR and oral temperature) |  | 9-days | 
| Safety and tolerability as measured by oxygen saturation |  | 9-days | 
| Safety and tolerability as measured by safety laboratory tests |  | 9-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Male, Pharmacokinetics