Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine
Phase 1
Completed
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Registration Number
- NCT01153386
- Lead Sponsor
- United Therapeutics
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 0.5 mg treprostinil diethanolamine Treprostinil diethanolamine 0.5 mg treprostinil diethanolamine 1 mg treprostinil diethanolamine Treprostinil diethanolamine 1 mg treprostinil diethanolamine 2.5 mg treprostinil diethanolamine Treprostinil diethanolamine 2.5 mg treprostinil diethanolamine
- Primary Outcome Measures
Name Time Method Treprostinil pharmacokinetics 36 hours 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.
- Secondary Outcome Measures
Name Time Method Adverse event monitoring From the first dose of treprostinil diethanolamine through the end of the study (Study Day 16) Clinical laboratories Study Days 0, 7, 14 and 16.
Trial Locations
- Locations (1)
PPD Development
🇺🇸Austin, Texas, United States