Three Times Daily Dosing of UT-15C

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: UT-15C

• Registration Number: NCT01746485
• Lead Sponsor: United Therapeutics

Brief Summary

To evaluate the pharmacokinetics of three-times daily dosing of UT-15C in healthy volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2012-08-16
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-07
• Last Update Submitted: 2012-12-10
• Study First Posted: 2012-12-11
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UT-15C	UT-15C	-

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) from 0-24hrs after 6 days of TID dosing.	6 days	Cmax, tmax, AUC(0-6), AUC(0-24), AUC(6-12), AUC(12-24) and t1/2

Secondary Outcome Measures

Name	Time	Method
PK profile of UT-15C after a single 0.5mg dose on Day 1	1 day	Day 1: Cmax, tmax, AUC(0-6), AUC(0-24), AUC(0-t), AUC(0-inf), and t1/2

Trial Locations

Locations (1)

PPD Development; 🇺🇸 Austin, Texas, United States