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

NCT02546635 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-02-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Artax Biopharma Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02546635 on ClinicalTrials.gov