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
  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:


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
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: 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
Esomeprazole
Treprostinil
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 22, 2014