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Completed

NCT Number: NCT00963001

Effect of Food on the Pharmacokinetics of Oral Treprostinil

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

treprostinil diethanolamine

Drug

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

Standardized meals

Other

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.

Primary outcomes

  1. 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)

  2. Adverse event monitoring

    Time frame: From the first dose of treprostinil diethanolamine through study end (Study Day 23/24)

Secondary outcomes

  1. Clinical laboratories

    Time frame: Study Days 0, 7, 14, 21 and 23

Sponsors and collaborators

Lead sponsor

United Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 20, 2009
Registry last updated
Mar 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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