Effect of Food on the Pharmacokinetics of Oral Treprostinil

Phase 1

Completed

• Conditions: Hypertension, Pulmonary; Pulmonary Arterial Hypertension

• Registration Number: NCT00963001
• Lead Sponsor: United Therapeutics

Brief Summary

The purpose of this study is to assess the pharmacokinetic and safety profile of a single dose of oral treprostinil following four different meals of varying caloric and fat content.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-19
• Study First Posted: 2009-08-20
• Study Start: 2009-09
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-05
• Last Update Posted: 2010-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Subject is healthy and between the ages of 18 and 55 years, inclusive, at Screening.
• Female subjects must weigh between 45 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 50 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

Primary Outcome Measures

Name	Time	Method
Adverse event monitoring	From the first dose of treprostinil diethanolamine through study end (Study Day 23/24)
Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of a 1 mg treprostinil diethanolamine sustained release tablet after four different meal types.	Immediately prior to through 36 hours post treprostinil diethanolamine dosing for each treatment period (4 treatment periods each separated by a 7-day washout period)

Secondary Outcome Measures

Name	Time	Method
Clinical laboratories	Study Days 0, 7, 14, 21 and 23

Trial Locations

Locations (1)

PPD Development; 🇺🇸 Austin, Texas, United States