NCT02546635

Potential Food Effect And Repeated Dosing of AX-024.HCl In Healthy Subjects

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Artax Biopharma Inc · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AX-024.HCl	AX-024.HCl will be administered as per the protocol defined frequency and dose level
DRUG	AX-024.HCl	AX-024.HCl will be administered as per the protocol defined frequency and dose level

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2015-09-11
• Last updated: 2016-02-09

Locations

1 site across 1 country: United Kingdom