Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-903 · 3 trials · 1 indication
Cmax of ABBV-903 will be assessed.
Tmax of ABBV-903 will be assessed.
Terminal phase elimination half-life (t1/2) will be assessed.
AUC0-t of ABBV-903 will be assessed.
AUC0-inf of ABBV-903 will be assessed.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Cmax of ABBV-903
Cmax of midazolam
Cmax of 1-OH-midazolam
Tmax of ABBV-903
Tmax of midazolam
Tmax of 1-OH-midazolam
Terminal phase elimination half-life of midazolam
Terminal phase elimination half-life of 1-OH-midazolam
AUCt of ABBV-903
AUCt of midazolam
AUCt of 1-OH-midazolam
AUCinf of ABBV-903
AUCinf of midazolam
AUCinf of 1-OH-midazolam
Cmax will be assessed.
Tmax will be assessed.
Apparent terminal phase elimination constant (β) will be assessed.
Terminal phase elimination half-life (t1/2) will be assessed.
AUC will be assessed.
AUCt will be assessed.
AUCinf will be assessed.
| Arm | Type | Description |
|---|---|---|
| ABBV-903 | EXPERIMENTAL | Participants will receive ABBV-903 on Day 1. |
| Part 1: Period 1 | EXPERIMENTAL | In Period 1 on Day 1, participants will receive liquid midazolam. |
| Part 1: Period 2 | EXPERIMENTAL | In Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 10, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days. |
| Part 2: Period 1 | EXPERIMENTAL | In Period 1 on Day 1, participants will receive liquid midazolam. |
| Part 2: Period 2 | EXPERIMENTAL | In Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 5, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days. |
| Part 1, ABBV-903 | EXPERIMENTAL | Participants will receive a single ascending dose of ABBV-903 in Part 1. |
| Part 1, Placebo | EXPERIMENTAL | Participants will receive a single ascending dose of placebo in Part 1. |
| Part 2, ABBV-903 | EXPERIMENTAL | Participants will receive multiple ascending doses of ABBV-903 in Part 2. |
| Part 2, Placebo | EXPERIMENTAL | Participants will receive multiple ascending doses of placebo in Part 2. |
| Part 3, Sequence 1 | EXPERIMENTAL | Participants in Part 3 will follow Sequence 1. |
| Part 3, Sequence 2 | EXPERIMENTAL | Participants in Part 3 will follow Sequence 2. |
| Name | Type | Description |
|---|---|---|
| ABBV-903 | DRUG | Solution; Oral |
| Midazolam | DRUG | Oral Liquid |
| Placebo for ABBV-903 | DRUG | Capsule; oral |
| Itraconazole | DRUG | Capsule; oral |
Inclusion Criteria: * Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal at Screening and upon initial confinement. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12...
ABBV-903 is an investigational small molecule drug being developed by AbbVie Inc. It has been studied in Phase 1 clinical trials in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed, and it remains in early clinical development.
ABBV-903 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. All three of the Phase 1 trials listed for ABBV-903 were conducted in the United States.
ABBV-903 is in Phase 1 clinical development. Three Phase 1 trials have been completed, with a total enrollment of 135 participants. No later-phase trials have been registered, and the drug is not approved for any indication.
ABBV-903 has been evaluated in three completed Phase 1 trials: NCT05691699, a single and multiple ascending dose study in 104 healthy adults; NCT05895266, a drug-drug interaction study with midazolam in 24 healthy volunteers; and NCT05995366, a mass balance study in 7 healthy male participants.
The ABBV-903 Phase 1 program included a single and multiple ascending dose study assessing adverse events and how the drug moves through the body, a drug-drug interaction study with midazolam, and a mass balance study using carbon-14 labeled ABBV-903. All three trials enrolled healthy volunteers and have been completed.
ABBV-903 is not approved. It is an investigational small molecule in Phase 1 clinical development, and all three registered trials have been completed. No indication for ABBV-903 has been disclosed.