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| Name | Class |
|---|---|
| Gedeon Richter Plc. | INDUSTRY |
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The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: ABBV-932 | Experimental | Participants will receive ABBV-932 on Day 1 and followed for 30 days. |
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| Part 1: Placebo | Placebo Comparator | Participants will receive placebo on Day 1 and followed for 30 days. |
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| Part 2: Sequence 1 | Experimental | Participants will receive ABBV-932 on Day 1 in Period 1 under fasting conditions and followed for 30 days. Participants will receive ABBV-932 with food on Day 1 in Period 2 and followed for 30 days. |
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| Part 2: Sequence 2 | Experimental | Participants will receive ABBV-932 with food on Day 1 in Period 1 and followed for 30 days. Participants will receive ABBV-932 on Day 1 in Period 2 under fasting conditions and followed for 30 days. |
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| Part 3: Japanese Participants: ABBV-932 | Experimental | Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-932 | Drug | Oral Capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of ABBV-932 | Cmax of ABBV-932. | Up to approximately 5 days |
| Time to Cmax (Tmax) of ABBV-932 | Tmax of ABBV-932. | Up to approximately 5 days |
| Terminal Phase Elimination Rate Constant (Beta) of ABBV-932 | Terminal phase elimination rate constant (beta) of ABBV-932. | Up to approximately 5 days |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-932 | Terminal phase elimination half-life of ABBV-932. | Up to approximately 5 days |
| Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932 | AUCt of ABBV-932. | Up to approximately 5 days |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932 | AUCinf of ABBV-932. | Up to approximately 5 days |
| Maximum Plasma Concentration (Cmax) of DCAR | Cmax of DCAR. | Up to approximately 5 days |
| Time to Cmax (Tmax) of DCAR | Tmax of DCAR. | Up to approximately 5 days |
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Inclusion Criteria:
Exclusion Criteria:
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials LLC /ID# 254178 | Anaheim | California | 92801-2658 | United States | ||
| Acpru /Id# 249639 |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| Part 3: Japanese Participants: Placebo |
| Placebo Comparator |
Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days. |
|
| Part 3: Han-Chinese Participants: ABBV-932 | Experimental | Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days. |
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| Placebo | Drug | Oral Capsule |
|
| Terminal Phase Elimination Rate Constant (Beta) of DCAR | Terminal phase elimination rate constant (beta) of DCAR. | Up to approximately 5 days |
| Terminal Phase Elimination Half-Life (t1/2) of DCAR | Terminal phase elimination half-life of DCAR. | Up to approximately 5 days |
| Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DCAR | AUCt of DCAR. | Up to approximately 5 days |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DCAR | AUCinf of DCAR. | Up to approximately 5 days |
| Maximum Plasma Concentration (Cmax) of DDCAR | Cmax of DDCAR. | Up to approximately 5 days |
| Time to Cmax (Tmax) of DDCAR | Tmax of DDCAR. | Up to approximately 5 days |
| Terminal Phase Elimination Rate Constant (Beta) of DDCAR | Terminal phase elimination rate constant (beta) of DDCAR. | Up to approximately 5 days |
| Terminal Phase Elimination Half-Life (t1/2) of DDCAR | Terminal phase elimination half-life of DDCAR. | Up to approximately 5 days |
| Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of DDCAR | AUCt of DDCAR. | Up to approximately 5 days |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of DDCAR | AUCinf of DDCAR. | Up to approximately 5 days |
| Grayslake |
| Illinois |
| 60030 |
| United States |