Back to resultsEffect of Food on the Pharmacokinetics of Oral Treprostinil
Primary Purpose
Hypertension, Pulmonary, Pulmonary Arterial Hypertension
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Treprostinil diethanolamine
Standardized meals
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring Hypertension, Pulmonary, Treprostinil, Pharmacokinetics, Treprostinil Diethanolamine, Pulmonary Arterial Hypertension
Eligibility 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.
Sites / Locations
- PPD Development
Outcomes
Primary Outcome Measures
Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of a 1 mg treprostinil diethanolamine sustained release tablet after four different meal types.
Adverse event monitoring
Secondary Outcome Measures
Clinical laboratories
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00963001
Brief Title
Effect of Food on the Pharmacokinetics of Oral Treprostinil
Official Title
Effect of Different Meal Types on the Pharmacokinetics of a Single 1 mg Oral Dose of UT-15C (Treprostinil Diethanolamine) Sustained Release Tablets in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
United Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the pharmacokinetic and safety profile of a single dose of oral treprostinil following four different meals of varying caloric and fat content.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary, Pulmonary Arterial Hypertension
Keywords
Hypertension, Pulmonary, Treprostinil, Pharmacokinetics, Treprostinil Diethanolamine, Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Treprostinil diethanolamine
Other Intervention Name(s)
UT-15C, UT-15C SR, Oral treprostinil
Intervention Description
Subjects will each receive a single 1 mg sustained release tablet of treprostinil diethanolamine by mouth within 10 minutes of consuming each of four standardized meals on Study Days 1, 8, 15, and 22.
Intervention Type
Other
Intervention Name(s)
Standardized meals
Intervention Description
Each subject will receive one of four different standardized meals of varying caloric and fat content in a randomized sequence such that all subjects will receive all four meals over the course of the study. Each subject will receive one standardized meal for breakfast on Study Days 1, 8, 15, and 22.
Primary Outcome Measure Information:
Title
Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of a 1 mg treprostinil diethanolamine sustained release tablet after four different meal types.
Time Frame
Immediately prior to through 36 hours post treprostinil diethanolamine dosing for each treatment period (4 treatment periods each separated by a 7-day washout period)
Title
Adverse event monitoring
Time Frame
From the first dose of treprostinil diethanolamine through study end (Study Day 23/24)
Secondary Outcome Measure Information:
Title
Clinical laboratories
Time Frame
Study Days 0, 7, 14, 21 and 23
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aziz Laurent, MD
Organizational Affiliation
PPD
Official's Role
Principal Investigator
Facility Information:
Facility Name
PPD Development
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Food on the Pharmacokinetics of Oral Treprostinil
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