NCT01746485

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
Last Updated

December 12, 2012

Status Verified

December 1, 2012

Enrollment Period

Same day

First QC Date

August 16, 2012

Last Update Submit

December 10, 2012

Conditions

Healthy

Keywords

Volunteers

Outcome Measures

Primary Outcomes (1)

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

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

    6 days

Secondary Outcomes (1)

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

    1 day

Study Arms (1)

UT-15C

EXPERIMENTAL
Drug: UT-15C

Interventions

UT-15CDRUG
Also known as: treprostinil diethanolamine, treprostinil diolamine, UT-15C SR
UT-15C

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

PPD Development

Austin, Texas, United States

Location

Related Publications (1)

  • Jones A, Wang-Smith L, Pham T, Laliberte K. Pharmacokinetics of 3 times a day dosing of oral treprostinil in healthy volunteers. J Cardiovasc Pharmacol. 2014 Mar;63(3):227-32. doi: 10.1097/FJC.0000000000000039.

    PMID: 24603117DERIVED

MeSH Terms

Interventions

treprostinil

Study Officials

  • Theresa Pham, MD

    PPD Development, LP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2012

First Posted

December 11, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 12, 2012

Record last verified: 2012-12

Locations

US(1)