Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05121714 | Evaluation of the Potential CYP1A2-mediated Drug Drug Interaction Safety, and Tolerability of ABX464 | PHASE1 | COMPLETED | 59 | — | — | Dec 17, 2020 | May 18, 2021 | Jan 5, 2022 | 1 | United Kingdom |
Peak Plasma Concentration (Cmax) for caffeine
Area under the plasma concentration versus time curve (AUC) for caffeine
Peak Plasma Concentration (Cmax) for ABX464
Area under the plasma concentration versus time curve (AUC) for ABX464
| Arm | Type | Description |
|---|---|---|
| Evaluation of CYP1A2 inhibition and induction potential by ABX464 | OTHER | Using a fixed-sequence crossover study design, the Pharmacokinetics (PK) of caffeine (50 milligrams (mg) single oral dose) will be evaluated in the absence and presence of ABX464 (50 mg once daily for 14 days) in 24 healthy subjects. Caffeine will be administered on Day 1 in the absence of ABX464, on Day 4 simultaneously with ABX464 to evaluate potential CYP1A2 inhibition by ABX464, and on Day 17 simultaneously with ABX464 following 14 days of once daily dosing of ABX464 to evaluate potential CYP1A2 induction by ABX464. |
| Evaluation of ABX464 as a substrate for CYP1A2 | OTHER | Using a fixed-sequence crossover study design, the PK of ABX464 (50 mg single oral dose) will be evaluated in the absence and presence of fluvoxamine (100 mg once daily for 10 days) in 36 healthy subjects. ABX464 will be administered on Day 1 in the absence of fluvoxamine and on Day 11 simultaneously with fluvoxamine following 10 days of once daily dosing of fluvoxamine to evaluate whether ABX464 is a substrate for CYP1A2 |
| Name | Type | Description |
|---|---|---|
| Caffeine | DRUG | This is a 2 part, fixed-sequence open-label, crossover study to evaluate the potential CYP1A2-mediated drug-drug interactions (DDI), safety, and tolerability of ABX464 combined with a known CYP1A2 substrate (caffeine) |
| ABX464 | DRUG | This is a 2 part, fixed-sequence open-label, crossover study to evaluate the potential CYP1A2-mediated drug-drug interactions (DDI), safety, and tolerability of ABX464 combined with a known CYP1A2 inhibitor (fluvoxamine) and a known CYP1A2 substrate (caffeine). |
| Fluvoxamine | DRUG | his is a 2 part, fixed-sequence open-label, crossover study to evaluate the potential CYP1A2-mediated drug-drug interactions (DDI), safety, and tolerability of ABX464 combined with a known CYP1A2 inhibitor (fluvoxamine). |
Inclusion Criteria: 1. Healthy, male or female subject, between 18 and 55 years of age, inclusive. 2. Women of childbearing potential (WOCBP) and men receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 6 months (180 day...