Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Caffeine · 1 trial · 1 indication
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...
Caffeine is a small molecule being developed by Abivax SA as a probe in a Phase 1 clinical trial. It is being studied in healthy volunteers to evaluate its potential as a CYP1A2-mediated drug-drug interaction agent. The drug is not approved and is still in clinical development.
Caffeine is being studied for use in healthy volunteers as part of a clinical trial to evaluate its potential for CYP1A2-mediated drug-drug interactions. It is not intended for a specific disease indication. The drug is investigational and not yet approved for any medical use.
Caffeine is being developed by Abivax SA, a biopharmaceutical company. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety, tolerability, and potential for drug-drug interactions in healthy volunteers.
Caffeine is in Phase 1 clinical development. It is being studied in a completed Phase 1 trial that evaluated its potential for CYP1A2-mediated drug-drug interactions, safety, and tolerability in healthy volunteers. The drug is investigational and not yet approved.
Caffeine is associated with one completed Phase 1 clinical trial, NCT05121714, titled 'Evaluation of the Potential CYP1A2-mediated Drug Drug Interaction Safety, and Tolerability of ABX464'. This trial enrolled 59 healthy volunteers in the United Kingdom and was not randomized or double-blind.
Caffeine is being studied as a potential inhibitor or substrate of the CYP1A2 enzyme, which is involved in drug metabolism. The clinical trial evaluates its potential for CYP1A2-mediated drug-drug interactions, meaning it may affect how other drugs are processed by the body.