Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine

This study has been completed.
Sponsor:
Information provided by:
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01153386
First received: June 28, 2010
Last updated: August 20, 2010
Last verified: August 2010
  Purpose

This study will compare the bioavailability and pharmacokinetics of the 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine tablet strengths in healthy volunteers.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Treprostinil diethanolamine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Evaluation of the Pharmacokinetic Linearity and Comparative Bioavailability of a Single Oral Dose of 0.5 mg, 1 mg and 2.5 mg UT-15C (Treprostinil Diethanolamine) SR Tablets in Healthy Volunteers in the Fed State

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Treprostinil pharmacokinetics [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
    Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine sustained release tablets immediately prior to through 36 hours post treprostinil diethanolamine dosing.


Secondary Outcome Measures:
  • Clinical laboratories [ Time Frame: Study Days 0, 7, 14 and 16. ] [ Designated as safety issue: Yes ]
  • Adverse event monitoring [ Time Frame: From the first dose of treprostinil diethanolamine through the end of the study (Study Day 16) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.5 mg treprostinil diethanolamine
0.5 mg treprostinil diethanolamine
Drug: Treprostinil diethanolamine
Treprostinil diethanolamine sustained release oral tablets.
Other Name: UT-15C
Experimental: 2.5 mg treprostinil diethanolamine
2.5 mg treprostinil diethanolamine
Drug: Treprostinil diethanolamine
Treprostinil diethanolamine sustained release oral tablets.
Other Name: UT-15C
Experimental: 1 mg treprostinil diethanolamine
1 mg treprostinil diethanolamine
Drug: Treprostinil diethanolamine
Treprostinil diethanolamine sustained release oral tablets.
Other Name: UT-15C

Detailed Description:

This study was designed to assess the pharmacokinetic linearity and comparative bioavailability of UT-15C SR (treprostinil diethanolamine) following the administration of a single tablet containing 0.5 mg, 1 mg and 2.5 mg UT-15C in healthy volunteers.

  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
  • Female subjects must weigh between 55 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 55 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: NCT01153386

Locations
United States, Texas
PPD Development
Austin, Texas, United States, 78744
Sponsors and Collaborators
United Therapeutics
Investigators
Principal Investigator: Thomas L Hunt, MD, PhD PPD
  More Information

No publications provided

Responsible Party: Allison Lim, United Therapeutics
ClinicalTrials.gov Identifier: NCT01153386     History of Changes
Other Study ID Numbers: TDE-PH-122
Study First Received: June 28, 2010
Last Updated: August 20, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by United Therapeutics:
Pulmonary arterial hypertension
Treprostinil
Pharmacokinetics

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 April 15, 2014