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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546635
• Other study ID #: AX-024.HCl-1.02
• Status: Completed
• Phase: Phase 1
• First received: August 11, 2015
• Last updated: February 8, 2016
• Start date: August 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Artax Biopharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Simbec Research Ltd	Merthyr Tydfil	Cardiff Road

Sponsors (2)

Lead Sponsor	Collaborator
Artax Biopharma Inc	Simbec Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Serious and Non-Serious Adverse Events	Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry)	10 days	Yes
Secondary	maximal concentration (Cmax)		PK collected at multiple visits during the 10 days of treatment	Yes
Secondary	Area under the plasma concentration versus time curve (AUC)		PK collected at multiple visits during the 10 days of treatment	Yes
Secondary	Time to reach steady state		PK collected at multiple visits during the 10 days of treatment	Yes