Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
Study NCT ID:
NCT03979859
Status:
COMPLETED
Last Update Posted:
2019-06-11
First Post:
2019-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers
Sponsor:
Wockhardt
Organization:
Study Overview
Official Title:
Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2019-06
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 Phase 1, randomized, double-blind, single center, placebo-controlled, sequential cohort study in a maximum of 3 cohorts of 10 healthy male and/or female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple oral doses of WCK 4873 or matching placebo once daily on Days 1 to 7. Dosing will be conducted under fed conditions on each dosing day. The dose levels to be administered will be based on the safety, tolerability and PK results of the single dose and food effect study (W 4873 01 study; PRA-code WOE384EC-123841).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: