Ignite Creation Date:
2024-05-06 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05065359
Status:
COMPLETED
Last Update Posted:
2022-07-13
First Post:
2021-08-02
Brief Title:
Multiple-Ascending Dose in Japanese Patients Bridging Study
Sponsor:
Altavant Sciences GmbH
Organization:
Altavant Sciences GmbH
Study Overview
Official Title:
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
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None