NCT05065359

Multiple-Ascending Dose in Japanese Patients Bridging Study

A Randomized, Double-Blinded, Placebo-Controlled, MultipleAscending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rodatristat Ethyl in Healthy Japanese and Caucasian Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Altavant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, placebo-controlled, multiple-ascending dose study in healthy Japanese and Caucasian subjects.

Detailed description

This study is a randomized, placebo-controlled, multiple-ascending dose study in healthy Japanese and Caucasian subjects. Two dose levels of rodatristat ethyl, 300 mg twice daily (BID) and 600 mg BID multiple doses (with a single dose lead in), will be explored in an ascending dose fashion with a safety review in between (Figure 1 below). Approximately 48 subjects will be enrolled in 4 cohorts.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rodatristat Ethyl 300 mg BID	Tablets, oral, 300 mg, BID 14 days
DRUG	Rodatristat Ethyl 600 mg BID	Tablets, oral, 600 mg, BID 14 days
DRUG	Placebo	Tablets, oral, 0 mg, BID for 14 days

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-03-30
• Completion: 2022-03-30
• First posted: 2021-10-04
• Last updated: 2022-07-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study