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The objective of this study is to evaluate the PK of a tablet formulation of ABBV-722 under fasted conditions and the effect of food on its bioavailability after administration of single doses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1: Single Dose A | Experimental | Single dose will be administered under fasted conditions |
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| Period 2: Single Dose A | Experimental | Single dose will be administered under fed (high-fat meal) conditions |
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| Period 3: Single Dose B | Experimental | Single dose will be administered under fasted conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-722 | Drug | Oral Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of ABBV-722 | Maximum observed plasma concentration (Cmax) of ABBV-722 | Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total) |
| Time to Cmax (Tmax) of ABBV-722 | Time to Cmax (Tmax) of ABBV-722 | Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total) |
| Terminal Phase Elimination Rate Constant (β) of ABBV-722 | Terminal phase elimination rate constant of ABBV-722 | Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total) |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-722 | Terminal phase elimination half-life of ABBV-722 | Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total) |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-722 | Area under the plasma concentration-time curve from time 0 to the time of last measurable concentration (AUCt) of ABBV-722 | Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total) |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-722 | Area under the plasma concentration-time curve from time 0 to infinite time (AUCinf) of ABBV-722 | Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total) |
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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# 279291 | Grayslake | Illinois | 60030 | United States |
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| Number of Participants with Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to 57 Days |