Ignite Creation Date:
2024-05-06 @ 3:02 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02186002
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2014-07-08
Brief Title:
Safety Tolerability Pharmacokinetics and Pharmacodynamics of ACT-451840 in Healthy Subjects Part A
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
Single-center Double-blind Placebo-controlled Randomized Single-ascending Dose With Nested Cross-over for Food Effect to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of ACT-451840 in Healthy Subjects Part A
Status:
COMPLETED
Status Verified Date:
2019-08
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:
The primary objective of the study was to evaluate the safety and tolerability of ACT-451840 in healthy male subjectsSecondary objectives were to investigate the pharmacokinetics PK of ACT-451840 to investigate the effect of food on the PK of ACT-451840 to evaluate the urinary excretion of ACT-451840 and to investigate the antimalarial activity of ACT-451840
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