Pulmonary Arterial Hypertension
Conditions
Keywords
Pulmonary arterial hypertension, Treprostinil, Pharmacokinetics
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.
Interventions
Treprostinil diethanolamine sustained release oral tablets.
Sponsors
United Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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) |
Countries
United States
Outcome results
None listed