Ignite Creation Date:
2024-05-06 @ 2:40 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02099201
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2014-03-26
Brief Title:
Study to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of ACT-389949 in Healthy Subjects
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
A Single-center Double-blind Parallel-group Randomized Placebo-controlled Multiple-ascending Oral Dose Study to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of ACT-389949 in Healthy 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 single-center double-blind parallel-group randomized placebo-controlled multiple-ascending oral dose study to investigate the safety tolerability pharmacokinetics and pharmacodynamics of ACT-389949 in healthy subjects
Part A of the study will evaluate the safety and tolerability following once a day oral dosing of ACT-389949 for 9 days and investigate ACT-389949 pharmacokinetics and pharmacodynamics
Part B of the study will evaluate the safety and tolerability of ACT-389949 following a maximum of two different oral dosing regimens ACT-389949 given either every 3 days for 13 days or every 2 days for 9 days 5 doses for each regimen
Part C of the study if required will provide additional information to that obtained from Parts A and B in terms of safety tolerability pharmacokinetics and pharmacodynamics of ACT-389949
Part A of the study will evaluate the safety and tolerability following once a day oral dosing of ACT-389949 for 9 days and investigate ACT-389949 pharmacokinetics and pharmacodynamics
Part B of the study will evaluate the safety and tolerability of ACT-389949 following a maximum of two different oral dosing regimens ACT-389949 given either every 3 days for 13 days or every 2 days for 9 days 5 doses for each regimen
Part C of the study if required will provide additional information to that obtained from Parts A and B in terms of safety tolerability pharmacokinetics and pharmacodynamics 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