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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: AX-024.HCl
* Drug: AX-024.HCl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Potential food effect<br> | Drug: AX-024.HCl<br>* AX-024.HCl will be administered as per the protocol defined frequency and dose level<br>|
| Experimental: Multi-dosing<br> | Drug: AX-024.HCl<br>* AX-024.HCl will be administered as per the protocol defined frequency and dose level<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Serious and Non-Serious Adverse Events | Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry) | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal concentration (Cmax) |  | PK collected at multiple visits during the 10 days of treatment | 
| Area under the plasma concentration versus time curve (AUC) |  | 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 |