A Single and Multiple Dose of Rodatristat Ethyl in Healthy Adult Subjects to Evaluate the Effect of Food and Safety
NCT05684640 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2023-01-27
Summary
This is a single and multiple dose food effect study of rodatristat ethyl in healthy subjects
Conditions
- Healthy
Interventions
- DRUG
-
Rodatristat Ethyl
Tablets, Oral, 600mg, QD
- DRUG
-
Tablets, Oral, 0mg, BID
Sponsors & Collaborators
-
PPD Development, LP
collaborator INDUSTRY -
Altavant Sciences GmbH
lead INDUSTRY
Principal Investigators
-
Thomas Hunt, MD · PPD Development, LP
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-09-29
- Primary Completion
- 2023-01-17
- Completion
- 2023-01-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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