PPD Development
Austin, Texas, 78744, United States
NCT Number: NCT00963001
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Austin, Texas, 78744, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: UT-15C, UT-15C SR, Oral treprostinil
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.
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)
Time frame: From the first dose of treprostinil diethanolamine through study end (Study Day 23/24)
Time frame: Study Days 0, 7, 14, 21 and 23
United Therapeutics
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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