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Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine

Primary Purpose

Pulmonary Arterial Hypertension

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Treprostinil diethanolamine

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Pulmonary arterial hypertension, Treprostinil, Pharmacokinetics

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

PPD Development

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

0.5 mg treprostinil diethanolamine

2.5 mg treprostinil diethanolamine

1 mg treprostinil diethanolamine

Arm Description

0.5 mg treprostinil diethanolamine

2.5 mg treprostinil diethanolamine

1 mg treprostinil diethanolamine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical laboratories

Adverse event monitoring

Full Information

NCT ID

NCT01153386

First Posted

June 28, 2010

Last Updated

August 20, 2010

Sponsor

United Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT01153386

Brief Title

Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine

Official Title

An Evaluation of the Pharmacokinetic Linearity and Comparative Bioavailability of a Single Oral Dose of 0.5 mg, 1 mg and 2.5 mg UT-15C (Treprostinil Diethanolamine) SR Tablets in Healthy Volunteers in the Fed State

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

United Therapeutics

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study was designed to assess the pharmacokinetic linearity and comparative bioavailability of UT-15C SR (treprostinil diethanolamine) following the administration of a single tablet containing 0.5 mg, 1 mg and 2.5 mg UT-15C in healthy volunteers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Arterial Hypertension

Keywords

Pulmonary arterial hypertension, Treprostinil, Pharmacokinetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

0.5 mg treprostinil diethanolamine

Arm Type

Experimental

Arm Description

0.5 mg treprostinil diethanolamine

Arm Title

2.5 mg treprostinil diethanolamine

Arm Type

Experimental

Arm Description

2.5 mg treprostinil diethanolamine

Arm Title

1 mg treprostinil diethanolamine

Arm Type

Experimental

Arm Description

1 mg treprostinil diethanolamine

Intervention Type

Drug

Intervention Name(s)

Treprostinil diethanolamine

Other Intervention Name(s)

UT-15C

Intervention Description

Treprostinil diethanolamine sustained release oral tablets.

Primary Outcome Measure Information:

Title

Treprostinil pharmacokinetics

Description

Time Frame

36 hours

Secondary Outcome Measure Information:

Title

Clinical laboratories

Time Frame

Study Days 0, 7, 14 and 16.

Title

Adverse event monitoring

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas L Hunt, MD, PhD

Organizational Affiliation

PPD

Official's Role

Principal Investigator

Facility Information:

Facility Name

PPD Development

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine

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