- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Cardiff Road
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Merthyr Tydfil, Cardiff Road, United Kingdom, CF48 4DR
- Simbec Research Ltd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Potential food effect
|
AX-024.HCl will be administered as per the protocol defined frequency and dose level
|
Experimental: Multi-dosing
|
AX-024.HCl will be administered as per the protocol defined frequency and dose level
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: 10 days
|
Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry)
|
10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
maximal concentration (Cmax)
Time Frame: PK collected at multiple visits during the 10 days of treatment
|
PK collected at multiple visits during the 10 days of treatment
|
Area under the plasma concentration versus time curve (AUC)
Time Frame: PK collected at multiple visits during the 10 days of treatment
|
PK collected at multiple visits during the 10 days of treatment
|
Time to reach steady state
Time Frame: PK collected at multiple visits during the 10 days of treatment
|
PK collected at multiple visits during the 10 days of treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AX-024.HCl-1.02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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