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The goal of this study is to determine the impact of the food on the absorption of the ABX464.
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:
This study consists of two groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasted Conditions | Experimental | 50mg of ABX464 (two 25mg capsules) /Fasted |
|
| Fed Conditions | Experimental | 50mg of ABX464 (two 25mg capsules) /Fed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABX464 Single dose | Drug | 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. |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAP Research | Sayed Hossen Road | Phoenix | Mauritius |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27799203 | Derived | 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. |
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| ID | Term |
|---|---|
| C000623073 | ABX464 |
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| ABX464 Repeated dose | Drug | Subjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition. |
|
| Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0 | Up to 45 days |