Skip to main content
OpenTrials
Completed

NCT Number: NCT02546635

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Simbec Research Ltd

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AX-024.HCl

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. maximal concentration (Cmax)

    Time frame: PK collected at multiple visits during the 10 days of treatment

  2. Area under the plasma concentration versus time curve (AUC)

    Time frame: PK collected at multiple visits during the 10 days of treatment

  3. Time to reach steady state

    Time frame: PK collected at multiple visits during the 10 days of treatment

Sponsors and collaborators

Lead sponsor

Artax Biopharma Inc

Industry

Collaborators

  • Simbec Research

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 11, 2015
Registry last updated
Feb 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.