Effect of Food on the Pharmacokinetics of Oral Treprostinil - Full Text View

Sponsor:	United Therapeutics
Information provided by:	United Therapeutics
ClinicalTrials.gov Identifier:	NCT00963001

Purpose

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.

Condition	Intervention	Phase
Hypertension, Pulmonary Pulmonary Arterial Hypertension	Drug: Treprostinil diethanolamine Other: Standardized meals	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: U 62840 Diethanolamine Remodulin

U.S. FDA Resources

Further study details as provided by United Therapeutics:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]
Adverse event monitoring [ Time Frame: From the first dose of treprostinil diethanolamine through study end (Study Day 23/24) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical laboratories [ Time Frame: Study Days 0, 7, 14, 21 and 23 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	32
Study Start Date:	September 2009
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Subjects will each receive a single 1 mg sustained release tablet of treprostinil diethanolamine by mouth within 10 minutes of consuming each of four standardized meals on Study Days 1, 8, 15, and 22.

Other Names:

UT-15C
UT-15C SR
Oral treprostinil

Each subject will receive one of four different standardized meals of varying caloric and fat content in a randomized sequence such that all subjects will receive all four meals over the course of the study. Each subject will receive one standardized meal for breakfast on Study Days 1, 8, 15, and 22.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963001

Locations

United States, Texas
PPD Development
Austin, Texas, United States, 78744

Sponsors and Collaborators

United Therapeutics

Investigators

Principal Investigator:

Aziz Laurent, MD

PPD

More Information

No publications provided

Responsible Party:	Allison Pecha, United Therapeutics Corp.
ClinicalTrials.gov Identifier:	NCT00963001 History of Changes
Other Study ID Numbers:	TDE-PH-115
Study First Received:	August 19, 2009
Last Updated:	March 5, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by United Therapeutics:

Hypertension, Pulmonary
Treprostinil
Pharmacokinetics
Treprostinil Diethanolamine
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:

Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012