The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil

Phase 1

Completed

• Conditions: Pulmonary Arterial Hypertension; Renal Dysfunction
• Interventions: Drug: UT-15C SR (treprostinil diethanolamine)

• Registration Number: NCT01131845
• Lead Sponsor: United Therapeutics

Brief Summary

This is a single-center, open-label, single-dose evaluation of 1 mg UT-15C SR pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end stage renal disease (ESRD; on dialysis).

Subjects in the ESRD group will receive 2 doses of UT-15C SR, separated by 14 days. One dose will be given 4 hours prior to dialysis, the other dose will be given at the end of dialysis.

Pharmacokinetic samples will be taken immediately prior to dosing and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 30, 36, 42 and 48 hours post dose. Additionally, subjects with ESRD will have a sample taken at 60 hrs post dose.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-27
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-16
• Last Update Posted: 2012-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treprostinil diethanolamine	UT-15C SR (treprostinil diethanolamine)	-

Primary Outcome Measures

Name	Time	Method
Treprostinil pharmacokinetics in volunteers with varying degrees of renal function following a single oral dose of a 1 mg treprostinil diethanolamine sustained release.	48hrs post dose (60 hours for ESRD)

Trial Locations

Locations (1)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States