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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AX-024.HCl

• Registration Number: NCT02546635
• Lead Sponsor: Artax Biopharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-11
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

• Subjects with a body mass index (BMI) of 18 - 35 kg/m2, inclusive. BMI = Body weight (kg) / [Height (m)]2.
• Subjects must not be vegetarians or consume abnormal diets.
• Subject with no clinically significant abnormal serum biochemistry, haematology coagulation (Part B only) and urine examination values within 21 days of the first dose.
• Subject with a negative urinary drugs of abuse screen, determined within 21 days of the first dose (N.B. a positive alcohol result may be repeated at the discretion of the Investigator).
• Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
• Subject with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 21 days of the first dose.
• Subject with no history of autoimmune disease, cardiac disease, kidney disease or any food intolerance.
• Male subject willing to use 2 effective methods of contraception i.e. established method of contraception + condom, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months afterwards.
• Subjects must be available to complete the study (including follow-up visit).
• Subjects must satisfy a medical examiner about their fitness to participate in the study
• Subjects must provide written informed consent to participate in the study

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Multi-dosing	AX-024.HCl	-
Potential food effect	AX-024.HCl	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Serious and Non-Serious Adverse Events	10 days	Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry)

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)	PK collected at multiple visits during the 10 days of treatment
maximal concentration (Cmax)	PK collected at multiple visits during the 10 days of treatment
Time to reach steady state	PK collected at multiple visits during the 10 days of treatment

Trial Locations

Locations (1)

Simbec Research Ltd; 🇬🇧 Merthyr Tydfil, Cardiff Road, United Kingdom