Healthy VolunteersPhase 1NCT02731885
Food Effect on Pharmacokinetic Parameters of ABX464
A Phase 1 study testing ABX464 Single dose and ABX464 Repeated dose in people with Healthy Volunteers, run by Abivax S.A. at 1 site in Mauritius.
Trial summary
The goal of this study is to determine the impact of the food on the absorption of the ABX464. 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 Volunteers
- What is being tested?
- ABX464 Single dose and ABX464 Repeated dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteMauritius
- Study dates
- Sep 2014to Jun 2015
- 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
- Healthy Caucasian male subjects, 18-55 years of age
- Body Mass Index (BMI) of 17-28 kg/m².
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)
- Normal vital signs after 10 minutes resting in supine position:
- 90 mmHg < systolic blood pressure < 140 mmHg, 50 mmHg < diastolic blood pressure < 90 mmHg, 40 bpm < heart rate < 100 bpm.
- Normal automatic 12-lead ECG (incomplete right bundle branch block can be accepted) or judged as non clinically significant.
- Clinical laboratory tests (hematology, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to Investigator and Sponsor.
- Subjects must be willing to give written informed consent prior to study enrollment and be able to adhere to restrictions and examination schedules.
Who cannot join
- Individuals with a history of any significant medical disorder which requires a physician's care (cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease; any acute infectious disease or signs of acute illness)
- Frequent headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month).
- Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician.
- Individuals who have a history of any clinically significant local or systemic infectious disease within 4 weeks prior to drug administration.
- Any individual who does not comply with the requirement that he should not have used any drugs other than paracetamol for at least 2 weeks prior to the study nor alcohol within 48 hours prior to drug administration.
- Individuals who are positive for hepatitis B virus, hepatitis C virus or HIV.
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- History or presence of drug or alcohol abuse (positive urine drug screen, positive alcohol breath test).
- Smoking more than 5 cigarettes or equivalent / day, unable to stop smoking during the study.
- Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day).
- Subject who will likely be unable to eat entirely the standard high fat breakfast within the allocated time.
- Individuals who have donated blood within the preceding 3 months.
- Individuals who refuse to use an effective method of contraception from the beginning of the study and until 3 months after dosing.
- Individuals with forfeiture of freedom by an administrative or legal obligation or under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Randomized Study, to Investigate the Potential Food Effect on Pharmacokinetic Parameters of ABX464 Administered Orally to Healthy Male Subjects
The goal of this study is to determine the impact of the food on the absorption of the ABX464.
Read the detailed description
This is a phase I, single-center, open-label, two-treatment, food-effect, randomized study in 40 healthy Caucasian male subjects in order to determine the impact of the food on the absorption of the ABX464.
The two different treatments are the followings:
- Treatment A = 50mg of ABX464 (two 25mg capsules) /Fasted
- Treatment B = 50mg of ABX464 (two 25mg capsules) / Fed
This study consists of two groups:
- Group 1 - single dose assessments, two-period, two-treatment, cross-over: 20 subjects will receive a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days.
- Group 2 - multiple dose assessments: 20 subjects will receive 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.
- Conditions
- Healthy Volunteers
- Being tested
- ABX464 Single dose, ABX464 Repeated dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX464 Single doseDrug
Two-periods, subjects received a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days.
ABX464 Repeated doseDrug
Subjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.
| Study group | Role | What they receive |
|---|---|---|
| Fasted Conditions | Experimental | 50mg of ABX464 (two 25mg capsules) /Fasted Receives: Drug: ABX464 Single dose; Drug: ABX464 Repeated dose |
| Fed Conditions | Experimental | 50mg of ABX464 (two 25mg capsules) /Fed Receives: Drug: ABX464 Single dose; Drug: ABX464 Repeated dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of single oral dose of 50mg of ABX464 in fed or fasted condition.
Measured: 45 days
Peak Plasma Concentration (Cmax) of single oral dose of 50mg of ABX464 in fed or fasted condition.
Measured: 45 days
Secondary outcomes (3)
Area under the plasma concentration versus time curve (AUC) of repeated doses of 50 mg of ABX464 in fed or fasted conditions
Measured: 10 days
Peak Plasma Concentration (Cmax) of repeated doses of 50 mg of ABX464 in fed or fasted conditions
Measured: 10 days
Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abivax S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731885
- Sponsor's protocol ID
- ABX464-FE-001
- Status last verified
- Apr 2016
- First submitted
- 25 Mar 2016
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Scherrer D, Rouzier R, Cardona M, Barrett PN, Steens JM, Gineste P, Murphy RL, Tazi J, Ehrlich HJ. Randomized Trial of Food Effect on Pharmacokinetic Parameters of ABX464 Administered Orally to Healthy Male Subjects. Antimicrob Agents Chemother. 2016 Dec 27;61(1):e01288-16. doi: 10.1128/AAC.01288-16. Print 2017 Jan.
PubMed 27799203
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized Study, to Investigate the Potential Food Effect on Pharmacokinetic Parameters of ABX464 Administered Orally to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02731885
- Acronym / sponsor ID
- ABX464-FE-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Abivax S.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Apr 2016 (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.
The goal of this study is to determine the impact of the food on the absorption of the ABX464.
Detailed description
This is a phase I, single-center, open-label, two-treatment, food-effect, randomized study in 40 healthy Caucasian male subjects in order to determine the impact of the food on the absorption of the ABX464.
The two different treatments are the followings:
- Treatment A = 50mg of ABX464 (two 25mg capsules) /Fasted
- Treatment B = 50mg of ABX464 (two 25mg capsules) / Fed
This study consists of two groups:
- Group 1 - single dose assessments, two-period, two-treatment, cross-over: 20 subjects will receive a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days.
- Group 2 - multiple dose assessments: 20 subjects will receive 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasted Conditions | Experimental | Drug: ABX464 Single dose, Drug: ABX464 Repeated dose50mg of ABX464 (two 25mg capsules) /Fasted |
| Fed Conditions | Experimental | Drug: ABX464 Single dose, Drug: ABX464 Repeated dose50mg of ABX464 (two 25mg capsules) /Fed |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy Caucasian male subjects, 18-55 years of age
- Body Mass Index (BMI) of 17-28 kg/m².
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)
- Normal vital signs after 10 minutes resting in supine position:
- 90 mmHg < systolic blood pressure < 140 mmHg, 50 mmHg < diastolic blood pressure < 90 mmHg, 40 bpm < heart rate < 100 bpm.
Key exclusion criteria (13 listed)
- Individuals with a history of any significant medical disorder which requires a physician's care (cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease; any acute infectious disease or signs of acute illness)
- Frequent headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month).
- Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician.
- Individuals who have a history of any clinically significant local or systemic infectious disease within 4 weeks prior to drug administration.
- Any individual who does not comply with the requirement that he should not have used any drugs other than paracetamol for at least 2 weeks prior to the study nor alcohol within 48 hours prior to drug administration.
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 |
|---|---|---|
| ABX464 Single doseTwo-periods, subjects received a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days. | Drug | Fasted Conditions, Fed Conditions |
| ABX464 Repeated doseSubjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition. | Drug | Fasted Conditions, Fed Conditions |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of single oral dose of 50mg of ABX464 in fed or fasted condition.
Time frame: 45 days
Peak Plasma Concentration (Cmax) of single oral dose of 50mg of ABX464 in fed or fasted condition.
Time frame: 45 days
3 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of repeated doses of 50 mg of ABX464 in fed or fasted conditions
Time frame: 10 days
Peak Plasma Concentration (Cmax) of repeated doses of 50 mg of ABX464 in fed or fasted conditions
Time frame: 10 days
Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Up to 45 days
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 8 Apr 2016.
- Derived from this study: PubMed 27799203Scherrer D, Rouzier R, Cardona M, Barrett PN, Steens JM, Gineste P, Murphy RL, Tazi J, Ehrlich HJ. Randomized Trial of Food Effect on Pharmacokinetic Parameters of ABX464 Administered Orally to Healthy Male Subjects. Antimicrob Agents Chemother. 2016 Dec 27;61(1):e01288-16. doi: 10.1128/AAC.01288-16. Print 2017 Jan.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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 ABX464 Single dose and ABX464 Repeated dose in people with Healthy Volunteers, run by Abivax S.A. at 1 site in Mauritius.
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 8 inclusion and 13 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 8 Apr 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 Mauritius. 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?
Area under the plasma concentration versus time curve (AUC) of single oral dose of 50mg of ABX464 in fed or fasted condition. (time frame: 45 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02731885, which also lists 1 linked publication.
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 8 Apr 2016.