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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06477926 | A Study to Assess Relative Bioavailability and Food Effect of ABBV-668 Extended-Release Formulations in Adult Participants | PHASE1 | COMPLETED | 25 | — | — | Jul 9, 2024 | Sep 20, 2024 | Oct 8, 2024 | 1 | United States |
Cmax of ABBV-668
Tmax of ABBV-668
Terminal phase elimination rate constant (beta) of ABBV-668
Terminal phase elimination half-life of ABBV-668
AUCt of ABBV-668
AUCinf of ABBV-688
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. The investigator assesses the relationship of each event to the use of study
| Arm | Type | Description |
|---|---|---|
| ABBV-668 Regimen A | EXPERIMENTAL | Participants will receive ABBV-668 Immediate Release (IR) capsules on Day 1 under fasting conditions |
| ABBV-668 Regimen B | EXPERIMENTAL | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fasting conditions |
| ABBV-668 Regimen C | EXPERIMENTAL | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fed conditions |
| ABBV-668 Regimen D | EXPERIMENTAL | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fasting conditions |
| ABBV-668 Regimen E | EXPERIMENTAL | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fed conditions |
| ABBV-668 Regimen F | EXPERIMENTAL | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fasting conditions |
| ABBV-668 Regimen G | EXPERIMENTAL | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fed conditions |
| Name | Type | Description |
|---|---|---|
| ABBV-668 IR | DRUG | • Oral Capsule |
| ABBV-668 ER | DRUG | • Oral Tablets |
Inclusion Criteria: * BMI is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at screening. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG. Exclusion Criteria: * History of any...