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A Single and Multiple Dose of Rodatristat Ethyl in Healthy Adult Subjects to Evaluate the Effect of Food and Safety

Healthy Clinical Trial

Official title:
A Single and Multiple Dose Study of Rodatristat Ethyl in Healthy Subjects to Evaluate the Effect of Food, and the Safety, Tolerability, and Pharmacokinetics of a Supratherapeutic Dose of Rodatristat Ethyl

Clinical Trial Summary

This is a single and multiple dose food effect study of rodatristat ethyl in healthy subjects

Clinical Trial Description

This is a two-part Phase 1 study. Part 1 is a single dose, randomized, open label, parallel, single site study designed to evaluate the effect of a high fat meal on the PK of rodatristat ethyl, rodatristat and metabolite(s). Part 2 is a randomized double-blind, placebo-controlled study to evaluate the safety and tolerability of repeat supratherapeutic dose of rodatristat ethyl when administered twice daily with a standard meal. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05684640
Study type Interventional
Source Altavant Sciences GmbH
Contact
Status Completed
Phase Phase 1
Start date September 29, 2022
Completion date January 17, 2023
View Details
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