Approval Probability
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Adjusted LOA
ML Risk
ABBV-CLS-616 · 1 trial · 1 indication
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...
ABBV-CLS-616 is an investigational small molecule drug candidate developed by AbbVie Inc. It is an oral tablet formulation that has been studied in healthy adult volunteers. It remains in clinical development and is not approved for any indication.
ABBV-CLS-616 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the drug candidate.
ABBV-CLS-616 is in Phase 1 clinical development. Its single recorded Phase 1 trial has been completed. The drug is investigational and has not been approved by the FDA for any indication.
ABBV-CLS-616 has been evaluated in one Phase 1 trial, NCT06698926, titled A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants. The trial enrolled 110 healthy adult volunteers in the United States and is completed.
The Phase 1 trial NCT06698926 was a randomized, double-blind, controlled study of ABBV-CLS-616 oral tablets in healthy adult participants. It enrolled 110 participants of all sexes, aged 18 years and older, at sites in the United States. The study is completed.