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Strategic considerations
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The purpose of this study is to evaluate the relative bioavailability of three immediate-release table formulations of ABBV-903 under fasting conditions in healthy volunteers, and to evaluate the effect of food on the pharmacokinetics of three immediate-release table formulations of ABBV-903.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, Sequence A | Experimental | Participants will receive 1 dose of ABBV-903. |
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| Part 1, Sequence B | Experimental | Participants will receive 1 dose of ABBV-903. |
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| Part 1, Sequence C | Experimental | Participants will receive 1 dose of ABBV-903. |
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| Part 2, Sequence A | Experimental | Participants will receive 1 dose of ABBV-903. |
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| Part 2, Sequence B | Experimental | Participants will receive 1 dose of ABBV-903. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-903 | Drug | Tablet; oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of ABBV-903 | Cmax of ABBV-903 will be assessed. | From 0 - 96 hours |
| Time to Cmax (Tmax) of ABBV-903 | Tmax of ABBV-903 will be assessed. | From 0 - 96 hours |
| Apparent Terminal Phase Elimination Constant (BETA) of ABBV-903 | BETA of ABBV-903 will be assessed. | From 0 - 96 hours |
| Terminal Phase Elimination Half-life (t1/2) of ABBV-903 | Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed. | From 0 - 96 hours |
| Area Under the Plasma Concentration-time Curve from Time 0 until 24 Hours after Dosing (AUC0-24) of ABBV-903 | AUC0-24 of ABBV-903 will be assessed. | From 0 - 96 hours |
| AUC from Time 0 until the Last Measurable Concentration (AUCt) of ABBV-903 | AUCt of ABBV-903 will be assessed. | From 0 - 96 hours |
| AUC from Time 0 to Infinite Time (AUCinf) of ABBV-903 | AUCinf of ABBV-903 will be assessed. | From 0 - 96 hours |
| Number of Participants with Adverse Events | 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. |
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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# 259438 | Grayslake | Illinois | 60030 | United States |
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| Up to 42 days |