NCT05684640

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Altavant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rodatristat Ethyl	Tablets, Oral, 600mg, QD
DRUG	Placebo	Tablets, Oral, 0mg, BID

Timeline

• Start date: 2022-09-29
• Primary completion: 2023-01-17
• Completion: 2023-01-17
• First posted: 2023-01-13
• Last updated: 2023-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study