Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine

NCT01153386 | Completed Phase 1

• 1 other identifier: TDE-PH-122
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the bioavailability and pharmacokinetics of the 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine tablet strengths in healthy volunteers.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary arterial hypertension; Treprostinil; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Treprostinil pharmacokinetics

  Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine sustained release tablets immediately prior to through 36 hours post treprostinil diethanolamine dosing.

  36 hours

Secondary Outcomes (2)

• Clinical laboratories

  Study Days 0, 7, 14 and 16.

• Adverse event monitoring

  From the first dose of treprostinil diethanolamine through the end of the study (Study Day 16)

Study Arms (3)

0.5 mg treprostinil diethanolamine

EXPERIMENTAL

0.5 mg treprostinil diethanolamine

Drug: Treprostinil diethanolamine

2.5 mg treprostinil diethanolamine

EXPERIMENTAL

2.5 mg treprostinil diethanolamine

Drug: Treprostinil diethanolamine

1 mg treprostinil diethanolamine

EXPERIMENTAL

1 mg treprostinil diethanolamine

Drug: Treprostinil diethanolamine

Interventions

Treprostinil diethanolamine DRUG

Treprostinil diethanolamine sustained release oral tablets.

Also known as: UT-15C

0.5 mg treprostinil diethanolamine; 1 mg treprostinil diethanolamine; 2.5 mg treprostinil diethanolamine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is healthy and between the ages of 18 and 55 years
• Female subjects must weigh between 55 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 55 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive at Screening.
• Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening.

You may not qualify if:

• Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
• Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
• Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary and/or musculoskeletal disease; glaucoma; a psychiatric disorder or any other chronic disease, whether controlled by medication or not.

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (1)

PPD Development

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Thomas L Hunt, MD, PhD

  PPD Development, LP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 30, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 23, 2010

Record last verified: 2010-08

Locations

US (1)