Food Effect on Pharmacokinetic Parameters of ABX464

ABIVAX

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ABX464 Repeated dose; Drug: ABX464 Single dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02731885

ABX464-FE-001

Details and patient eligibility

About

The goal of this study is to determine the impact of the food on the absorption of the ABX464.

Full 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.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Fasted Conditions

Experimental group

Description:

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

Treatment:

Drug: ABX464 Repeated dose

Drug: ABX464 Single dose

Fed Conditions

Experimental group

Description:

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

Treatment:

Drug: ABX464 Repeated dose

Drug: ABX464 Single dose