HealthyPhase 1NCT02546635
Potential Food Effect And Repeated Dosing of AX-024.HCl In Healthy Subjects
A Phase 1 study testing AX-024.HCl in people with Healthy, run by Artax Biopharma Inc at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AX-024.HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Jan 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec Research Ltd
Merthyr Tydfil, Cardiff Road, CF48 4DR
About this study
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
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).
Read more
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
- Being tested
- AX-024.HCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AX-024.HClDrug
AX-024.HCl will be administered as per the protocol defined frequency and dose level
AX-024.HClDrug
AX-024.HCl will be administered as per the protocol defined frequency and dose level
| Study group | Role | What they receive |
|---|---|---|
| Potential food effect | Experimental | Not described Receives: Drug: AX-024.HCl |
| Multi-dosing | Experimental | Not described Receives: Drug: AX-024.HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious and Non-Serious Adverse Events
Physical status (Vital signs; 12-lead ECG; Urinalysis; Haematology and biochemistry)
Measured: 10 days
Secondary outcomes (3)
maximal concentration (Cmax)
Measured: PK collected at multiple visits during the 10 days of treatment
Area under the plasma concentration versus time curve (AUC)
Measured: PK collected at multiple visits during the 10 days of treatment
Time to reach steady state
Measured: PK collected at multiple visits during the 10 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artax Biopharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546635
- Sponsor's protocol ID
- AX-024.HCl-1.02
- Status last verified
- Feb 2016
- First submitted
- 11 Aug 2015
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02546635
- Acronym / sponsor ID
- AX-024.HCl-1.02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Artax Biopharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potential food effect | Experimental | Drug: AX-024.HCl |
| Multi-dosing | Experimental | Drug: AX-024.HCl |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AX-024.HClAX-024.HCl will be administered as per the protocol defined frequency and dose level | Drug | Potential food effect |
| AX-024.HClAX-024.HCl will be administered as per the protocol defined frequency and dose level | Drug | Multi-dosing |
Primary outcome
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)
3 secondary outcomes
maximal concentration (Cmax)
Time frame: 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
Time to reach steady state
Time frame: PK collected at multiple visits during the 10 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AX-024.HCl in people with Healthy, run by Artax Biopharma Inc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Serious and Non-Serious Adverse Events (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.