Ignite Creation Date:
2024-05-06 @ 9:07 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02905253
Status:
TERMINATED
Last Update Posted:
2018-07-10
First Post:
2016-08-31
Brief Title:
A Study to Evaluate if AC-084 is Safe Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
A Three-part Single-center Phase 1 Study to Assess the Tolerability Safety Pharmacokinetics Including Food Interaction and Pharmacodynamics of Ascending Single and Multiple Doses of AC-084 in Healthy Subjects and to Investigate the Pharmacokinetics of a Single Dose of AC-084 in Healthy CYP2C9 Poor Metabolizers
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study has been terminated due to difficulties in recruiting subjects into Part C No safety concerns contributed to the termination of the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this first-in-man study is to investigate whether AC-084 is safe and well-tolerated when orally administered at single- and multiple-ascending dose to healthy adults
Detailed Description:
The study is designed in three parts A B and C
Part A single-center double-blind randomized placebo-controlled single ascending dose
Part B single-center double-blind randomized placebo-controlled multiple ascending dose
Part C single-center open-label single dose in CYP2C9 poor metabolizers
Part A single-center double-blind randomized placebo-controlled single ascending dose
Part B single-center double-blind randomized placebo-controlled multiple ascending dose
Part C single-center open-label single dose in CYP2C9 poor metabolizers
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