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Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil

This study has been completed.
Sponsor:
Information provided by:
United Therapeutics
ClinicalTrials.gov Identifier:
NCT00963027
First received: August 19, 2009
Last updated: March 5, 2010
Last verified: March 2010
History of Changes
  Purpose

The purpose of this study is to evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics.


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

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Evaluation of Single Dose UT-15C SR (Treprostinil Diethanolamine) Pharmacokinetics Following Repeated Dosing With the Proton Pump Inhibitor Esomeprazole in Healthy Adult Volunteers

Resource links provided by NLM:

U.S. FDA Resources

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 before and after repeated dosing with esomeprazole. [ Time Frame: Within 10 minutes prior to through 36 hours post treprostinil diethanolamine dosing ] [ Designated as safety issue: No ]
  • Adverse event monitoring [ Time Frame: Time Frame: From the first dose of treprostinil diethanolamine through study end (Study Day 9/10) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical laboratories [ Time Frame: Study Days 0 and 9 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2009
Study Completion Date: October 2009
Primary Completion Date: October 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 immediately following breakfast before and after repeated daily dosing with esomeprazole.
    Other Names:
    • UT-15C
    • UT-15C SR
    • Oral treprostinil
    Drug: Esomeprazole
    Each subject will receive a single 40 mg capsule of esomeprazole by mouth in the morning for seven days.
    Other Name: Nexium
Detailed Description:

This open-label study will evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics following a single 1 mg oral dose of UT-15C SR 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, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963027

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

No publications provided

Responsible Party: Allison Pecha, United Therapeutics, Corp.
ClinicalTrials.gov Identifier: NCT00963027     History of Changes
Other Study ID Numbers: TDE-PH-116
Study First Received: August 19, 2009
Last Updated: March 5, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Omeprazole
Proton Pump Inhibitors
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013