Trials / Terminated
TerminatedNCT03884465
Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of Treprostinil
A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Liquidia Technologies, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Acute and chronic hemodynamic dose-response and safety evaluation of LIQ861 in PAH subjects.
Detailed description
Data will be collected on acute and chronic hemodynamic response to inhaled dry powder treprostinil (LIQ861) via right-heart catheterization. Study subjects will contribute to the overall safety profile of LIQ861.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inhaled dry powder treprostinil (LIQ861) | Inhaled dry powder treprostinil (LIQ861) at 25μg, 50μg, 75μg, or 100μg capsule strengths. Single dose in the acute setting. QID in the chronic setting. |
Timeline
- Start date
- 2019-11-11
- Primary completion
- 2020-12-23
- Completion
- 2020-12-23
- First posted
- 2019-03-21
- Last updated
- 2021-09-13
Locations
3 sites across 2 countries: France, Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03884465. Inclusion in this directory is not an endorsement.