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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06698926 | A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants | PHASE1 | COMPLETED | 110 | — | — | Nov 11, 2024 | Jan 9, 2026 | Jan 15, 2026 | 1 | United States |
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Part 1: Group 1 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose A or placebo after fasting on Day 1 and will be confined for 19 days. |
| Part 1: Group 2 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose B or placebo after fasting on Day 1 and will be confined for 19 days. |
| Part 1: Group 3 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose C or placebo after fasting on Day 1 and will be confined for 8 days. |
| Part 1: Group 4 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose D or placebo after fasting on Day 1 and will be confined for 8 days. |
| Part 1: Group 5 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose E or placebo after fasting on Day 1 and will be confined for 8 days. |
| Part 1: Group 6 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose F or placebo after fasting on Day 1 and will be confined for 8 days. |
| Part 2: Group 7 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose G or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 2: Group 8 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose H or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 2: Group 9 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose D or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 2: Group 10 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose E or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 2: Group 11 | EXPERIMENTAL | Participants will receive either ABBV-CLS-616 Dose F or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days. |
| Part 3: Sequence 1 | EXPERIMENTAL | In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1 after fasting and will be confined for 7 days. In Period 2, participants will receive ABBV-CLS-616 Dose C on Day 1, without fasting and will be confined for 8 days. |
| Part 3: Sequence 2 | EXPERIMENTAL | In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1 without fasting and will be confined for 7 days. In Period 2, participants will receive ABBV-CLS-616 Dose C on Day 1, after fasting and will be confined for 8 days. |
| Part 4: Itraconazole | EXPERIMENTAL | In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1, after fasting and will be confined for 7 days. In Period 2, participants will receive Itraconazole daily for 10 days without fasting and will receive ABBV-CLS-616 Dose C on Day 4 after fasting. Participants will be confined for 11 days. |
| Name | Type | Description |
|---|---|---|
| ABBV-CLS-616 | DRUG | Oral Tablet |
| Placebo | DRUG | Oral Tablet |
| Itraconazole | DRUG | Oral Capsule |
Inclusion Criteria: * Part 2 only: Participant must have normal platelet count at screening and upon initial confinement. * Part 2 only: Participant must not have known or suspected coagulopathy, or prothrombin time (PT)/activated partial thromboplastin time (aPTT)/international normalized ratio (I...