Hypertension, Pulmonary, Pulmonary Arterial Hypertension
Conditions
Keywords
Hypertension, Pulmonary, Treprostinil, Pharmacokinetics, Treprostinil Diethanolamine, Pulmonary Arterial Hypertension, Esomeprazole
Brief summary
The purpose of this study is to evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics.
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.
Interventions
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.
DRUGEsomeprazole
Each subject will receive a single 40 mg capsule of esomeprazole by mouth in the morning for seven days.
Sponsors
United Therapeutics
Study design
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Adverse event monitoring | Time Frame: From the first dose of treprostinil diethanolamine through study end (Study Day 9/10) |
Secondary
| Measure | Time frame |
|---|---|
| Clinical laboratories | Study Days 0 and 9 |
Countries
United States
Outcome results
None listed