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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05995366 | A Study to Assess the Mass Balance of [14C] ABBV-903 in Healthy Male Participants Following Single Oral Dose Administration | PHASE1 | COMPLETED | 7 | — | — | Aug 18, 2023 | Oct 13, 2023 | Oct 26, 2023 | 1 | United States |
| NCT05895266 | A Study to Assess Drug-Drug Interaction Between ABBV-903 and Midazolam in Adult Healthy Volunteers | PHASE1 | COMPLETED | 24 | — | — | Jun 23, 2023 | Nov 2, 2023 | Nov 9, 2023 | 1 | United States |
| NCT05691699 | A Study to Assess Adverse Events and How Single and Multiple Ascending Doses of ABBV-903 Move Through the Body in Healthy Adults | PHASE1 | COMPLETED | 104 | — | — | Jan 3, 2023 | Oct 23, 2023 | Oct 30, 2023 | 1 | United States |
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...