Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00963027
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : March 8, 2010
Information provided by:
United Therapeutics

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

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Pulmonary Arterial Hypertension Drug: Treprostinil diethanolamine Drug: Esomeprazole Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : September 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

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

Primary Outcome Measures :
  1. 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 ]
  2. Adverse event monitoring [ Time Frame: Time Frame: From the first dose of treprostinil diethanolamine through study end (Study Day 9/10) ]

Secondary Outcome Measures :
  1. Clinical laboratories [ Time Frame: Study Days 0 and 9 ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00963027

United States, Texas
PPD Development
Austin, Texas, United States, 78744
Sponsors and Collaborators
United Therapeutics
Principal Investigator: Aziz Laurent, MD PPD

Responsible Party: Allison Pecha, United Therapeutics, Corp. Identifier: NCT00963027     History of Changes
Other Study ID Numbers: TDE-PH-116
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: March 8, 2010
Last Verified: March 2010

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

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents