Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil

NCT00963027 | Completed Phase 1

• 1 other identifier: TDE-PH-116
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Keywords

Hypertension, Pulmonary; Treprostinil; Pharmacokinetics; Treprostinil Diethanolamine; Pulmonary Arterial Hypertension; Esomeprazole

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Clinical laboratories

  Study Days 0 and 9

Interventions

Treprostinil diethanolamine DRUG

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.

Also known as: UT-15C, UT-15C SR, Oral treprostinil

Esomeprazole DRUG

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

Also known as: Nexium

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (1)

PPD Development

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Interventions

treprostinil; Esomeprazole

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Aziz Laurent, MD

  PPD Development, LP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 8, 2010

Record last verified: 2010-03

Locations

US (1)