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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00963027
Other study ID # TDE-PH-116
Secondary ID
Status Completed
Phase Phase 1
First received August 19, 2009
Last updated March 5, 2010
Start date September 2009
Est. completion date October 2009

Study information

Verified date March 2010
Source United Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.
Esomeprazole
Each subject will receive a single 40 mg capsule of esomeprazole by mouth in the morning for seven days.

Locations

Country Name City State
United States PPD Development Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
United Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Within 10 minutes prior to through 36 hours post treprostinil diethanolamine dosing No
Primary Adverse event monitoring Time Frame: From the first dose of treprostinil diethanolamine through study end (Study Day 9/10) Yes
Secondary Clinical laboratories Study Days 0 and 9 Yes
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