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OpenTrials
Completed

NCT Number: NCT01746485

Three Times Daily Dosing of UT-15C

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development

Austin, Texas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Healthy male and female subjects
  • aged 18-55 years of age;
  • weight between 50 and 100 kg, with a body mass index (BMI) between 19.0 and 29.9 kg/m2, inclusive for female subjects and
  • weight between 50 and 120 kg, with a BMI between 19.0 and 32.0 kg/m², inclusive for male subjects.

Treatment and study plan

UT-15C

Drug

Other names: treprostinil diethanolamine, treprostinil diolamine, UT-15C SR

Primary outcomes

  1. Area under the curve (AUC) from 0-24hrs after 6 days of TID dosing.

    Time frame: 6 days

    Cmax, tmax, AUC(0-6), AUC(0-24), AUC(6-12), AUC(12-24) and t1/2

Secondary outcomes

  1. PK profile of UT-15C after a single 0.5mg dose on Day 1

    Time frame: 1 day

    Day 1: Cmax, tmax, AUC(0-6), AUC(0-24), AUC(0-t), AUC(0-inf), and t1/2

Sponsors and collaborators

Lead sponsor

United Therapeutics

Industry

Registry information

Official study title

A PK Evaluation of Three Times Daily Dosing of UT-15C SR Tablets in Healthy Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 11, 2012
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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