Trials / Completed
CompletedNCT03464864
Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers
A Phase 1, Single-center, Open-label, Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder (TrIP) in Healthy Normal Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Mannkind Corporation · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
A Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers
Detailed description
Up to 48 subjects will be enrolled in 8 cohorts of 6 subjects each. The treatments are intended to establish the maximum tolerated dose in healthy normal volunteers, starting at 30 mcg. Each subject will receive one dose of Treprostinil Inhalation Powder by oral inhalation during the treatment period. A total of 12 pharmacokinetic blood samples will be collected from each subject. Plasma pharmacokinetic samples will be analyzed for treprostinil.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Treprostinil Inhalation Powder | Single ascending dose |
Timeline
- Start date
- 2018-03-09
- Primary completion
- 2018-06-05
- Completion
- 2018-06-05
- First posted
- 2018-03-14
- Last updated
- 2018-10-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03464864. Inclusion in this directory is not an endorsement.