Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT02318758
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2014-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Interaction of Oral Treprostinil and Ethanol in Healthy Volunteers
Sponsor:
United Therapeutics
Organization:
Study Overview
Official Title:
Randomized, Single Dose, 4-Way Cross-over Study to Investigate the Pharmacokinetic Interaction of Oral Treprostinil and Ethanol in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TDE-PH-125
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: