Food Effect on Pharmacokinetic Parameters of ABX464

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ABX464 Single dose; Drug: ABX464 Repeated dose

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mauritius
  • Phoenix
    • Sayed Hossen road, Phoenix, Mauritius
      • CAP Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasted Conditions; 50mg of ABX464 (two 25mg capsules) /Fasted	Drug: ABX464 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.; Drug: ABX464 Repeated dose; Subjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.
Experimental: Fed Conditions; 50mg of ABX464 (two 25mg capsules) /Fed	Drug: ABX464 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.; Drug: ABX464 Repeated dose; Subjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Abivax S.A.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 25, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (Estimate): April 8, 2016

Study Record Updates

• Last Update Posted (Estimate): April 8, 2016
• Last Update Submitted That Met QC Criteria: April 4, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: ABX464-FE-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED