Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00963027 |
Date of registration:
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19/08/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil
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Scientific title:
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An Evaluation of Single Dose UT-15C SR (Treprostinil Diethanolamine) Pharmacokinetics Following Repeated Dosing With the Proton Pump Inhibitor Esomeprazole in Healthy Adult Volunteers |
Date of first enrolment:
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September 2009 |
Target sample size:
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30 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00963027 |
Study type:
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Interventional |
Study design:
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Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Aziz Laurent, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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PPD |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension, Pulmonary
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Esomeprazole
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Drug: Treprostinil diethanolamine
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Primary Outcome(s)
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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]
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Adverse event monitoring
[Time Frame: Time Frame: From the first dose of treprostinil diethanolamine through study end (Study Day 9/10)]
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Secondary Outcome(s)
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Clinical laboratories
[Time Frame: Study Days 0 and 9]
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Secondary ID(s)
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TDE-PH-116
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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