Status:
COMPLETED
Effect of Food on the Pharmacokinetics of Oral Treprostinil
Lead Sponsor:
United Therapeutics
Conditions:
Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00963001
Start Date
September 1 2009
End Date
November 1 2009
Last Update
March 8 2010
Active Locations (1)
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1
PPD Development
Austin, Texas, United States, 78744