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| Name | Class |
|---|---|
| Calico Life Sciences LLC | INDUSTRY |
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This is a Phase 1, first in human, randomized, four-part study to investigate the safety, tolerability, and pharmacokinetics of ABBV-CLS-616 after oral dosing in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-CLS-616 | Drug | Oral Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | 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. | Up to approximately 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 270532 | Grayslake | Illinois | 60030 | United States |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Placebo | Drug | Oral Tablet |
|
| Itraconazole | Drug | Oral Capsule |
|
| D010879 |
| Piperazines |