NCT02318758

Pharmacokinetic Interaction of Oral Treprostinil and Ethanol in Healthy Volunteers

Randomized, Single Dose, 4-Way Cross-over Study to Investigate the Pharmacokinetic Interaction of Oral Treprostinil and Ethanol in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A study to assess the interaction of acohol and oral treprostinil.

Detailed description

This study will compare the effects of ethanol on the PKs of a 1 mg dose of UT-15C in healthy volunteers to determine the in vivo effects of ethanol, including the timing of ethanol consumption in relation to UT-15C ingestion. This is an open-label, randomized, single-center, four-way (period), crossover study in which 28 healthy volunteers will receive a single 1 mg oral dose of UT-15C and/or ethanol. Eligible subjects will be randomly assigned to one of four treatment sequences such that all subjects will receive all four sequences in a pre-specified order.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	UT-15C	sustained release oral treprostinil
OTHER	ethanol	Absolut 100 vodka

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2014-12-17
• Last updated: 2015-03-24

Locations

1 site across 1 country: United States