Healthy Volunteers
Conditions
Brief summary
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.
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.
Sponsors
Abivax S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration versus time curve (AUC) of single oral dose of 50mg of ABX464 in fed or fasted condition. | 45 days |
| Peak Plasma Concentration (Cmax) of single oral dose of 50mg of ABX464 in fed or fasted condition. | 45 days |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration versus time curve (AUC) of repeated doses of 50 mg of ABX464 in fed or fasted conditions | 10 days |
| Peak Plasma Concentration (Cmax) of repeated doses of 50 mg of ABX464 in fed or fasted conditions | 10 days |
| Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0 | Up to 45 days |
Countries
Mauritius
Outcome results
None listed