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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014