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The objectives of this study are to assess safety and tolerability of the new ABBV-668 ER tablets, to assess the oral bioavailability of the ABBV-668 ER tablets relative to the ABBV-668 IR capsules, and to assess the pharmacokinetics of the ER tablets under fasting and fed conditions in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-668 Regimen A | Experimental | Participants will receive ABBV-668 Immediate Release (IR) capsules on Day 1 under fasting conditions |
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| ABBV-668 Regimen B | Experimental | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fasting conditions |
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| ABBV-668 Regimen C | Experimental | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fed conditions |
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| ABBV-668 Regimen D | Experimental | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fasting conditions |
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| ABBV-668 Regimen E | Experimental | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fed conditions |
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| ABBV-668 Regimen F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-668 IR | Drug | • Oral Capsule |
| |
| ABBV-668 ER |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of ABBV-668 | Cmax of ABBV-668 | Up to approximately 47 days |
| Time to Cmax (Tmax) of ABBV-668 | Tmax of ABBV-668 | Up to approximately 47 days |
| Terminal Phase Elimination Rate Constant (Beta) of ABBV-668 | Terminal phase elimination rate constant (beta) of ABBV-668 | Up to approximately 47 days |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-668 | Terminal phase elimination half-life of ABBV-668 | Up to approximately 47 days |
| Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-668 | AUCt of ABBV-668 | Up to approximately 47 days |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-688 | AUCinf of ABBV-688 | Up to approximately 47 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. The investigator assesses the relationship of each event to the use of study | Up to Day 47 |
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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# 266960 | Grayslake | Illinois | 60030 | United States |
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| Experimental |
Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fasting conditions |
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| ABBV-668 Regimen G | Experimental | Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fed conditions |
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| Drug |
• Oral Tablets |
|