Effect of Food on the Pharmacokinetics of Oral Treprostinil

United Therapeutics

Status and phase

Completed

Phase 1

Conditions

Hypertension, Pulmonary

Pulmonary Arterial Hypertension

Treatments

Other: Standardized meals

Drug: Treprostinil diethanolamine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00963001

TDE-PH-115

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.