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CompletedNCT02731885Updated Apr 8, 2016

Food Effect on Pharmacokinetic Parameters of ABX464

A Phase 1 interventional study of ABX464 Single dose and ABX464 Repeated dose in Healthy Volunteers, sponsored by Abivax S.A.. Completed at 1 site in Mauritius. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-08.

Sponsored by Abivax S.A. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

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.
02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Abivax S.A. is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Browse Abivax S.A. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Fasted Conditions

    50mg of ABX464 (two 25mg capsules) /Fasted

    Drug: ABX464 Single dose · Drug: ABX464 Repeated dose

  • Experimental
    Fed Conditions

    50mg of ABX464 (two 25mg capsules) /Fed

    Drug: ABX464 Single dose · Drug: ABX464 Repeated dose

Interventions

  • DrugABX464 Single dose

    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.

  • DrugABX464 Repeated dose

    Subjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.

06

What researchers measure

Primary outcomes

  1. 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

  2. Peak Plasma Concentration (Cmax) of single oral dose of 50mg of ABX464 in fed or fasted condition.

    Time frame: 45 days

Secondary outcomes

  1. 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

  2. Peak Plasma Concentration (Cmax) of repeated doses of 50 mg of ABX464 in fed or fasted conditions

    Time frame: 10 days

  3. Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: Up to 45 days

07

Study locations

1 site
  • CAP Research
    Sayed Hossen Road, Phoenix, Mauritius
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2014, a primary completion of Jun 2015 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2016
First posted
Apr 8, 2016
Start
Sep 2014
Primary completionActual
Jun 2015
CompletionActual
Jun 2015
Last update
Apr 8, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02731885
Lead sponsor
Abivax S.A.
Responsible party
Sponsor
First posted
Apr 8, 2016
Start date
Sep 2014
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Apr 8, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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