Effect of Different Meal Types on the Pharmacokinetics of a Single 1 mg Oral Dose of UT-15C (Treprostinil Diethanolamine) Sustained Release Tablets in Healthy Volunteers

United Therapeutics1 site in 1 country32 target enrollmentSeptember 2009

ConditionsHypertension, Pulmonary Pulmonary Arterial Hypertension

DrugsTreprostinil diethanolamine

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hypertension, Pulmonary
Sponsor: United Therapeutics
Enrollment: 32
Locations: 1
Primary Endpoint: Adverse event monitoring
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

November 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

United Therapeutics

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Adverse event monitoring

Time Frame: 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.

Time Frame: 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)