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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05836506 | A Study to Assess the Relative Bioavailability of Immediate Release Formulations of ABBV-903 in Healthy Adult Participants | PHASE1 | COMPLETED | 24 | — | — | Apr 18, 2023 | Jun 20, 2023 | Jul 17, 2023 | 1 | United States |
An 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
Tmax of ABBV-903
Terminal phase elimination half-life of ABBV-903
AUCt of ABBV-903
AUCinf of ABBV-903
| Arm | Type | Description |
|---|---|---|
| Part 1: Sequence A | EXPERIMENTAL | In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 1 after a high fat meal. Participants will be followed up for 30 days. |
| Part 1: Sequence B | EXPERIMENTAL | In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Participants will be followed up for 30 days. |
| Part 2: Sequence A | EXPERIMENTAL | In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 2 after a high fat meal. Participants will be followed up for 30 days. |
| Part 2: Sequence B | EXPERIMENTAL | In Period 1 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. In Period 2 on Day 1, participants will receive ABBV-903 Tablet Form 1 after fasting. Lastly, in Period 3 on Day 1, participants will receive ABBV-903 Tablet Form 2 after fasting. Participants will be followed up for 30 days. |
| Name | Type | Description |
|---|---|---|
| ABBV-903 Tablet Form 1 | DRUG | Oral Tablets |
| ABBV-903 Tablet Form 2 | DRUG | Oral Tablets |
Inclusion Criteria: * BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth. * Negative test result for SARS-CoV-2 infection at screening visit and upon initial confinement. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, labor...