Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-03-10 @ 7:23 PM
Study NCT ID:
NCT02546635
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2015-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Potential Food Effect And Repeated Dosing of AX-024.HCl In Healthy Subjects
Sponsor:
Artax Biopharma Inc
Organization:
Study Overview
Official Title:
A Safety, Tolerability, and Pharmacokinetic Clinical Trial of AX-024.HCl to Evaluate A) Potential Food Effect and B) Multi-dosing in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2016-02
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:
Part A: Food effect (a single oral dose of 500 mg AX-024.HCl under fasted and fed states) Eight (8) healthy male volunteers will receive a single dose of 500 mg AX-024.HCl in the fasted state (10 h overnight fast), and will return 2 weeks later to receive the same dose of AX-024.HCl following a meal.
Part B: Multiple doses (a once daily dose of AX-024.HCl or Placebo for 10 days).
Part B is a double-blind, dose escalating, placebo controlled, randomised, multiple dose study to assess the tolerability, safety and pharmacokinetics in 24 healthy male subjects. Subjects will be allocated to one of 2 dosing cohorts. Each cohort will have 12 subjects with 9 subjects randomised to receive AX-024.HCl and 3 subjects randomised to receive placebo.
There will be a data review following each dose level. Dose administration in the subsequent cohorts will only proceed after satisfactory data review on the blinded safety data and plasma PK data in the previous cohort.
Part B: Multiple doses (a once daily dose of AX-024.HCl or Placebo for 10 days).
Part B is a double-blind, dose escalating, placebo controlled, randomised, multiple dose study to assess the tolerability, safety and pharmacokinetics in 24 healthy male subjects. Subjects will be allocated to one of 2 dosing cohorts. Each cohort will have 12 subjects with 9 subjects randomised to receive AX-024.HCl and 3 subjects randomised to receive placebo.
There will be a data review following each dose level. Dose administration in the subsequent cohorts will only proceed after satisfactory data review on the blinded safety data and plasma PK data in the previous cohort.
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?: