Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine

United Therapeutics

Status and phase: Completed; Phase 1

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Treprostinil diethanolamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01153386

TDE-PH-122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

0.5 mg treprostinil diethanolamine

Experimental group

Description:

0.5 mg treprostinil diethanolamine

Treatment:

Drug: Treprostinil diethanolamine

2.5 mg treprostinil diethanolamine

Experimental group

Description:

2.5 mg treprostinil diethanolamine

Treatment:

Drug: Treprostinil diethanolamine

1 mg treprostinil diethanolamine

Experimental group

Description:

1 mg treprostinil diethanolamine

Treatment:

Drug: Treprostinil diethanolamine