Ignite Creation Date:
2024-05-06 @ 2:39 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02099071
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2014-03-26
Brief Title:
Study to Investigate the Tolerability Safety Pharmacokinetics and Pharmacodynamics of ACT-389949
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
Single-center Double-blind Randomized Placebo-controlled Single-ascending Dose and Food Interaction Study to Investigate the Tolerability Safety Pharmacokinetics and Pharmacodynamics of ACT-389949 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2018-07
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 is a prospective single-center double-blind randomized placebo-controlled ascending single oral dose and food interaction Phase 1 study It will evaluate the safety tolerability pharmacokinetics and pharmacodynamics of ascending single oral doses of ACT-389949 in healthy male subjects It will also investigate the effect of food on the pharmacokinetics safety and tolerability of a single dose of ACT-389949
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None