Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine

Study Overview
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Brief Summary
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This study will compare the bioavailability and pharmacokinetics of the 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine tablet strengths in healthy volunteers.

Detailed Description
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This study was designed to assess the pharmacokinetic linearity and comparative bioavailability of UT-15C SR (treprostinil diethanolamine) following the administration of a single tablet containing 0.5 mg, 1 mg and 2.5 mg UT-15C in healthy volunteers.

Official Title
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An Evaluation of the Pharmacokinetic Linearity and Comparative Bioavailability of a Single Oral Dose of 0.5 mg, 1 mg and 2.5 mg UT-15C (Treprostinil Diethanolamine) SR Tablets in Healthy Volunteers in the Fed State

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Drug: Treprostinil diethanolamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is healthy and between the ages of 18 and 55 years Female subjects must weigh between 55 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 55 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive at Screening. Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening. Exclusion Criteria: Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations. Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug. Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary and/or musculoskeletal disease; glaucoma; a psychiatric disorder or any other chronic disease, whether controlled by medication or not.

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

Sexes Eligible for Study
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All

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: 0.5 mg treprostinil diethanolamine<br>0.5 mg treprostinil diethanolamine | Drug: Treprostinil diethanolamine<br>* Treprostinil diethanolamine sustained release oral tablets.<br>* Other names: UT-15C;|
| Experimental: 2.5 mg treprostinil diethanolamine<br>2.5 mg treprostinil diethanolamine | Drug: Treprostinil diethanolamine<br>* Treprostinil diethanolamine sustained release oral tablets.<br>* Other names: UT-15C;|
| Experimental: 1 mg treprostinil diethanolamine<br>1 mg treprostinil diethanolamine | Drug: Treprostinil diethanolamine<br>* Treprostinil diethanolamine sustained release oral tablets.<br>* Other names: UT-15C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treprostinil pharmacokinetics | Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine sustained release tablets immediately prior to through 36 hours post treprostinil diethanolamine dosing. | 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical laboratories |  | Study Days 0, 7, 14 and 16. | 
| Adverse event monitoring |  | From the first dose of treprostinil diethanolamine through the end of the study (Study Day 16) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary arterial hypertension, Treprostinil, Pharmacokinetics