Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis

PHASE1CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

January 31, 2010

Study Completion Date

April 30, 2010

Conditions
Systemic Sclerosis
Interventions
DRUG

treprostinil diethanolamine

Cohort 1: Single 1 mg treprostinil diethanolamine sustained release tablet dose

DRUG

treprostinil diethanolamine

Cohort 2: treprostinil diethanolamine sustained release doses will be escalated up to a target dose of 4 mg BID

Trial Locations (3)

21224

Johns Hopkins Scleroderma Center, Baltimore

48016

University of Michigan Scleroderma Program, Ann Arbor

02118

Boston University School of Medicine Rheumatology Arthritis Center, Boston

Sponsors
All Listed Sponsors
lead

United Therapeutics

INDUSTRY