Effect of Food on the Pharmacokinetics of Oral Treprostinil

Completed · Phase 1

Conditions studied: Hypertension, Pulmonary, Pulmonary Arterial Hypertension

In brief

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.

Key facts

Study ID: NCT00963001
Run by: United Therapeutics
People needed: 32
Starts: 2009-09-01
Expected to finish: 2009-11-01
Last updated by the study team: 2010-03-08

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

PPD Development — Austin, Texas, United States

Full record on ClinicalTrials.gov

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