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Effect of Food on the Pharmacokinetics of Oral Treprostinil

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00963001
First Posted: August 20, 2009
Last Update Posted: March 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
United Therapeutics
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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:


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) ]
  • Adverse event monitoring [ Time Frame: From the first dose of treprostinil diethanolamine through study end (Study Day 23/24) ]

Secondary Outcome Measures:
  • Clinical laboratories [ Time Frame: Study Days 0, 7, 14, 21 and 23 ]

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:
    Drug: Treprostinil diethanolamine
    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
    Other: Standardized meals
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Allison Pecha, United Therapeutics Corp.
ClinicalTrials.gov Identifier: NCT00963001     History of Changes
Other Study ID Numbers: TDE-PH-115
First Submitted: August 19, 2009
First Posted: August 20, 2009
Last Update Posted: March 8, 2010
Last Verified: March 2010

Keywords provided by United Therapeutics:
Hypertension, Pulmonary
Treprostinil
Pharmacokinetics
Treprostinil Diethanolamine
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents


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