Food Effect on Pharmacokinetic Parameters of ABX464

• Register: ClinicalTrials.gov
• Last refreshed on: 18 April 2016
• Main ID: NCT02731885
• Date of registration: 25/03/2016
• Prospective Registration: No
• Primary sponsor: Abivax S.A.
• Public title: Food Effect on Pharmacokinetic Parameters of ABX464
• Scientific title: An Open, Randomized Study, to Investigate the Potential Food Effect on Pharmacokinetic Parameters of ABX464 Administered Orally to Healthy Male Subjects
• Date of first enrolment: September 2014
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02731885
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Mauritius

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Drug: ABX464 Repeated dose

Drug: ABX464 Single dose

Primary Outcome(s)

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]

Secondary Outcome(s)

Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0 [Time Frame: Up to 45 days]

Peak Plasma Concentration (Cmax) of repeated doses of 50 mg of ABX464 in fed or fasted conditions [Time Frame: 10 days]

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]

Secondary ID(s)

ABX464-FE-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors