Ignite Creation Date:
2024-05-06 @ 2:48 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02134964
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2014-05-07
Brief Title:
Phase 1 Safety and PK Study of OLT1177 Capsules
Sponsor:
Olatec Therapeutics LLC
Organization:
Olatec Therapeutics LLC
Study Overview
Official Title:
A Phase 1 Randomized Dose Escalation Single Center Safety and Pharmacokinetic Study of Single and Multi-Dose Orally Administered OLT1177 Capsules in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2015-03
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:
This study is a randomized placebo-controlled sequential ascending-dose study of healthy volunteers after administration of single or multiple doses of investigational drug OLT1177 Caps or Placebo Caps A total of 36 subjects will be enrolled across 6 cohorts and subjects in each cohort will be randomized in a ratio of 5 active to 1 placebo
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