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Strategic considerations
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This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese participants. This study will also assess drug-drug interaction between itraconazole and ABBV-1088 in healthy adult Western participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Group 1 ABBV-1088 Dose A | Experimental | Participants will receive ABBV-1088 dose A for 7 days |
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| Part 1: Group 1 Placebo | Experimental | Participants will receive placebo for 7 days |
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| Part 1: Group 2 ABBV-1088 Dose B | Experimental | Participants will receive ABBV-1088 dose B for 21 days |
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| Part 1: Group 2 Placebo | Experimental | Participants will receive placebo for 21 days |
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| Part 1: Group 3 ABBV-1088 Dose C | Experimental | Participants will receive ABBV-1088 dose C for 7 days |
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| Part 1: Group 3 Placebo | Experimental | Participants will receive placebo for 7 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-1088 | Drug | Oral Capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1, 2 and 3: Maximum Plasma Concentration (Cmax) of ABBV-1088 | Cmax of ABBV-1088 | Up to approximately 24 days |
| Part 1, 2 and 3: Time to Cmax (Tmax) of ABBV-1088 | Tmax of ABBV-1088 | Up to approximately 24 days |
| Part 1, 2 and 3: Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088 | Terminal phase elimination rate constant (beta) of ABBV-1088 | Up to approximately 24 days |
| Part 1, 2 and 3: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088 | Terminal phase elimination half-life of ABBV-1088 | Up to approximately 24 days |
| Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of ABBV-1088 | AUCt of ABBV-1088 | Up to approximately 24 days |
| Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of ABBV-1088 | AUCinf of ABBV-1088 | Up to approximately 24 days |
| Number of Participants with Adverse Events (AEs) | 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 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 |
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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 |
|---|---|---|---|---|---|---|
| CenExel ACT- Anaheim Clinical Trials /ID# 276423 | Anaheim | California | 92801 | United States | ||
| Acpru /Id# 270552 |
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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 4 ABBV-1088 Dose D | Experimental | Participants will receive ABBV-1088 dose D for 21 days |
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| Part 1: Group 4 Placebo | Experimental | Participants will receive placebo for 21 days |
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| Part 1: Group 5 ABBV-1088 Dose D | Experimental | Participants older than 60 years of age will receive ABBV-1088 dose D for 21 days |
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| Part 1: Group 5 Placebo | Experimental | Participants older than 60 years of age will receive placebo for 21 days |
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| Part 2: Period 1 ABBV-1088 Dose A | Experimental | Participants will receive ABBV-1088 Dose A on day 1 |
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| Part 2: Period 2 ABBV-1088 Dose A with ITZ | Experimental | Participants will receive ABBV-1088 dose A on day 4 with itraconazole (ITZ) for 10 days |
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| Part 3: Group 1 ABBV-1088 Han Chinese Participants | Experimental | Han Chinese participants will receive ABBV-1088 dose E on day 1 |
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| Part 3: Group 2 ABBV-1088 Japanese Participants | Experimental | Japanese participants will receive ABBV-1088 dose E on day 1 |
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| Placebo for ABBV-1088 | Drug | Oral Capsule |
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| Itraconazole (ITZ) | Drug | Oral Capsule |
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| Up to approximately 54 days |
| Part 1: Trough Concentration (Ctrough) of ABBV-1088 | Ctrough of of ABBV-1088 | Up to approximately 24 days |
| Part 1: Area Under the Plasma Concentration-time Curve (AUC) for the First and Final Dose Intervals (AUCtau) | The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau). | Up to approximately 24 days |
| Grayslake |
| Illinois |
| 60030 |
| United States |
| D010879 |
| Piperazines |