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

NCT02546635 | Completed Phase 1

• 1 other identifier: AX-024.HCl-1.02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Serious and Non-Serious Adverse Events

  Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry)

  10 days

Secondary Outcomes (3)

• 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

Study Arms (2)

Potential food effect

EXPERIMENTAL

Drug: AX-024.HCl

Multi-dosing

EXPERIMENTAL

Drug: AX-024.HCl

Interventions

AX-024.HCl DRUG

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

Potential food effect

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Artax Biopharma Inc: lead
• Simbec Research: collaborator

Study Sites (1)

Simbec Research Ltd

Merthyr Tydfil, Cardiff Road, CF48 4DR, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: September 11, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

GB (1)