Effect of Food on the Pharmacokinetics of Oral Treprostinil

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00963001
• Date of registration: 19/08/2009
• Prospective Registration: Yes
• Primary sponsor: United Therapeutics
• Public title: Effect of Food on the Pharmacokinetics of Oral Treprostinil
• Scientific 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
• Date of first enrolment: September 2009
• Target sample size: 32
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00963001
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Aziz Laurent, MD
• Affiliation: PPD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Hypertension, Pulmonary

Intervention(s)

Other: Standardized meals

Drug: Treprostinil diethanolamine

Primary Outcome(s)

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)]

Secondary Outcome(s)

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

Secondary ID(s)

TDE-PH-115

Source(s) of Monetary Support

Please refer to primary and secondary sponsors