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This study will assess the pharmacokinetic and safety profile of treprostinil following fixed and escalating doses of treprostinil diethanolamine SR tablets. Open-label, two-part study assessing the pharmacokinetics, safety, and tolerability of oral treprostinil diethanolamine SR. Cohort 1: single 1 mg treprostinil diethanolamine SR dose. Cohort 2: escalating doses of treprostinil diethanolamine SR up to a target dose of 4 mg BID.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treprostinil diethanolamine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treprostinil diethanolamine | Drug | Cohort 1: Single 1 mg treprostinil diethanolamine sustained release tablet dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: treprostinil pharmacokinetics in patients with systemic sclerosis following single oral administration of a 1 mg treprostinil diethanolamine SR dose. | pre-24hrs post dose | |
| Cohort 2: treprostinil pharmacokinetics at dose levels of 2 mg BID and 4 mg BID, respectively, in patients with systemic sclerosis following repeated oral administration of treprostinil diethanolamine SR tablets | 0-12 hrs post-dose | |
| adverse event monitoring | Cohort 1:Day 0 to Day 2; Cohort 2: Day 0 to Day 47 |
| Measure | Description | Time Frame |
|---|---|---|
| clinical laboratories | Cohort 1: Day 0 and Day 2; Cohort 2: Day 0 and Day 47 | |
| Cohort 2: Raynauds Phenomenon Visual Analoge Scale | 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristan Rollins, PharmD | United Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Scleroderma Center | Baltimore | Maryland | 21224 | United States | ||
| Boston University School of Medicine Rheumatology Arthritis Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23597147 | Derived | Shah AA, Schiopu E, Hummers LK, Wade M, Phillips K, Anderson C, Wise R, Boin F, Seibold JR, Wigley F, Rollins KD. Open label study of escalating doses of oral treprostinil diethanolamine in patients with systemic sclerosis and digital ischemia: pharmacokinetics and correlation with digital perfusion. Arthritis Res Ther. 2013 Apr 18;15(2):R54. doi: 10.1186/ar4216. |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C427248 | treprostinil |
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| treprostinil diethanolamine | Drug | Cohort 2: treprostinil diethanolamine sustained release doses will be escalated up to a target dose of 4 mg BID |
|
| Boston |
| Massachusetts |
| 02118 |
| United States |
| University of Michigan Scleroderma Program | Ann Arbor | Michigan | 48016 | United States |