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This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-1042 or Placebo-Group 1 | Experimental | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. |
|
| ABBV-1042 or Placebo-Group 2 | Experimental | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. |
|
| ABBV-1042 or Placebo-Group 3 | Experimental | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. |
|
| ABBV-1042 or Placebo-Group 4 | Experimental | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. |
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| ABBV-1042 or Placebo-Group 5 | Experimental | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. |
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| ABBV-1042 or Placebo-Group 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-1042 | Drug | Oral Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | An 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. | Up to approximately 32 days |
| Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements | Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed. | Up to approximately 3 days |
| Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior. | Up to approximately 3 days |
| Number of Participants with Abnormal Change in Physical Examinations | Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, and neurological systems will be assessed. | Up to approximately 3 days |
| Number of Participants with Change from Baseline in Electrocardiogram (ECG) | 12-lead resting ECG will be recorded. | Up to approximately 3 days |
| Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed | Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 279405 | Recruiting | Grayslake | Illinois | 60030 | United States |
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| Experimental |
Participants will receive an oral dose of ABBV-1042 or placebo on day 1. |
|
| Placebo | Drug | Oral Solution |
|
| Up to approximately 3 days |
| Maximum Plasma Concentration (Cmax) of ABBV-1042 | Cmax of ABBV-1042 | Up to approximately 3 days |
| Time to Cmax (Tmax) of ABBV-1042 | Tmax of ABBV-1042 | Up to approximately 3 days |
| Apparent terminal phase elimination constant (β) of ABBV-1042 | β of ABBV-1042 | Up to approximately 3 days |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-1042 | t1/2 of ABBV-1042 | Up to approximately 3 days |
| Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of ABBV-1042 | AUCt of ABBV-1042 | Up to approximately 3 days |
| Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of ABBV-1042 | AUCinf of ABBV-1042 | Up to approximately 3 days |