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This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France).
This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France). Six subjects per dose group were enrolled into 1 of 4 groups with escalating doses of ABX464 (50, 100, 150 and 200 mg). For each dose group, a first subject was treated, if no adverse event (AE) occurred, a second subject was dosed one hour later. The four last subjects were dosed the day after if no clinically significant AE occurred. Escalation to the following dose level was decided after review of PK and safety data (laboratory results, ECG, vital signs and AEs)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABX464 | Experimental | 50, 100, 150 or 200 mg once a day / Single Administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABX464 | Drug | Single Administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients experiencing at least one Adverse Event | Up to 45 days post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentrations (Cmax) of ABX464 and metabolite | Up to 45 days post dosing | |
| Area Under the Curve (AUC) of Plasma Concentrations of ABX464 and metabolite | Up to 45 days post dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Cap | Montpellier | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27999038 | Derived | Scherrer D, Rouzier R, Noel Barrett P, Steens JM, Gineste P, Murphy RL, Tazi J, Ehrlich HJ. Pharmacokinetics and tolerability of ABX464, a novel first-in-class compound to treat HIV infection, in healthy HIV-uninfected subjects. J Antimicrob Chemother. 2017 Mar 1;72(3):820-828. doi: 10.1093/jac/dkw458. |
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| ID | Term |
|---|---|
| C000623073 | ABX464 |
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