Ignite Creation Date:
2024-05-06 @ 12:08 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01493596
Status:
COMPLETED
Last Update Posted:
2021-04-20
First Post:
2011-11-28
Brief Title:
A Safety Tolerability and Pharmacokinetic Study of CPP-115
Sponsor:
Catalyst Pharmaceuticals Inc
Organization:
Catalyst Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Double-blind Placebo-controlled Single Ascending Dose Study of the Safety Tolerability and Pharmacokinetics of CPP-115 Solution Administered Orally to Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2021-03
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:
Primary Objective
To evaluate the safety and tolerability of ascending single oral doses of CPP-115
Secondary Objective
To determine the pharmacokinetic profiles of CPP-115 following administration of a ascending single oral doses
To evaluate the safety and tolerability of ascending single oral doses of CPP-115
Secondary Objective
To determine the pharmacokinetic profiles of CPP-115 following administration of a ascending single oral doses
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