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Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities

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 treprostinil, bioavailability, bioequivalence

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, inclusive, at Screening
Female subjects must weigh between 45 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 50 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 Type

Active Comparator

Experimental

Arm Label

manufacturer #1

manufacturer #2

Arm Description

treprostinil diethanolamine from manufacturer #1

treprostinil diethanolamine from manufacturer #2

Outcomes

Primary Outcome Measures

Treprostinil pharmacokinetics

Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 1mg treprostinil diethanolamine collecting pre and post-dose levels to 36 hours.

Secondary Outcome Measures

Clinical lab values

Adverse event monitoring

Full Information

NCT ID

NCT01165476

First Posted

July 15, 2010

Last Updated

April 18, 2011

Sponsor

United Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT01165476

Brief Title

Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities

Official Title

An Evaluation of the Comparative Bioavailability of a Single Oral Dose of 1mg UT-15C (Treprostinil Diethanolamine) SR Tablets Manufactured by Two Independent Facilities Administered to Healthy Volunteers in the Fed State

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

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

The purpose of this study is to compare the bioavailability of a single 1mg dose of treprostinil diethanolamine sustained release (SR) tablets manufactured by two independent facilities.

6. Conditions and Keywords

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

Pulmonary Arterial Hypertension

Keywords

treprostinil, bioavailability, bioequivalence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

manufacturer #1

Arm Type

Active Comparator

Arm Description

treprostinil diethanolamine from manufacturer #1

Arm Title

manufacturer #2

Arm Type

Experimental

Arm Description

treprostinil diethanolamine from manufacturer #2

Intervention Type

Drug

Intervention Name(s)

Treprostinil diethanolamine

Intervention Description

sustained release tablets. One 1mg tablet per period. Two total doses.

Primary Outcome Measure Information:

Title

Treprostinil pharmacokinetics

Description

Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 1mg treprostinil diethanolamine collecting pre and post-dose levels to 36 hours.

Time Frame

36 hours

Secondary Outcome Measure Information:

Title

Clinical lab values

Time Frame

Days 0, 7 and 9

Title

Adverse event monitoring

Time Frame

From signing of ICF to end of study

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, inclusive, at Screening Female subjects must weigh between 45 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 50 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

Aziz L Laurent, MD

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

Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities

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