Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-932 · 10 trials · 8 indications
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.
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
12-lead resting ECG will be recorded.
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
SAS (Simpson-Angus Scale): is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Minimum: 0 (no symptoms) Maximum: 40 (very severe symptoms; 10 items scored 0-4 each).
AIMS (Abnormal Involuntary Movement Scale): assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. Minimum: 0 (no abnormal movements) Maximum: 42 (most severe; 7 items scored 0-4 each), some versions use 0-4 on 10 items for a max of 40/40.
BARS (Barnes Akathisia Rating Scale): is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia. Minimum: 0 (no akathisia) Maximum: 14 (severe akathisia; 4 items scored, most items 0-3 or 0-5)
C-SSRS rates an individual's degree of suicidal ideation (SI) and behaviors on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
ESS (Epworth Sleepiness Scale): is a scale that is intended to measure daytime sleepiness. Minimum: 0 (no sleepiness) Maximum: 24 (severe sleepiness; 8 items scored 0-3 each)
The YMRS (Young Mania Rating Scale): is an 11-item, clinician-rated scale that assesses manic symptoms based on the participant's perception of their condition over the previous 48 hours, as well as the physician's clinical observations during the interview. Minimum: 0 (no mania) Maximum: 60 (severe mania; 11 items, some scored 0-4, others 0-8)
Number of participants with abnormal change in ocular examinations in areas like best corrected visual acuity (BCVA), and refraction.
An AE is defined as any untoward medical occurrence in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
The HAM-A is a 14-item, clinician-reported measure used to quantify and categorize the participant's anxiety over the past week. Items are rated on a 5-point Likert rating scale. The HAM-A total score ranges from 0 to 56, with higher scores indicating greater anxiety severity.
The MADRS is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.
Cmax of ABBV-932
Tmax of ABBV-932
Terminal phase elimination half-life of ABBV-932
AUCt of ABBV-932
AUCinf of ABBV-932
Ctrough of ABBV-932
AUCtau of ABBV-932
Cmax of DCAR
Tmax of DCAR
Ctrough of DCAR
AUCtau of DCAR
Cmax of DDCAR
Tmax of DDCAR
Ctrough of DDCAR
AUCtau of DDCAR
Cmax of ABBV-932 and active metabolites DCAR and DDCAR
Tmax of ABBV-932 and active metabolites DCAR and DDCAR
Ctrough of ABBV-932 and active metabolites DCAR and DDCAR
(β) of ABBV-932 and active metabolites DCAR and DDCAR
Terminal phase elimination half-life of ABBV-932 and active metabolites DCAR and DDCAR
AUCt of ABBV-932 and active metabolites DCAR and DDCAR
AUCinf of ABBV-932 and active metabolites DCAR and DDCAR
Terminal phase elimination rate constant (beta) of ABBV-932
Dopamine D2 and D3 Receptor Occupancy in the brain up to Day 14 after multiple doses of ABBV-932 will be measured by PET. The occupancies will be determined by evaluating the difference in the binding potential (BPND) measured between baseline and post-dose scans in various brain regions.
Cmax will be assessed.
Tmax will be assessed.
Ctrough will be assessed.
AUCtau will be assessed.
Terminal phase elimination rate constant (beta) of DCAR.
Terminal phase elimination half-life of DCAR.
AUCt of DCAR.
AUCinf of DCAR.
Cmax of DDCAR.
Terminal phase elimination rate constant (beta) of DDCAR.
Terminal phase elimination half-life of DDCAR.
AUCt of DDCAR.
AUCinf of DDCAR.
| Arm | Type | Description |
|---|---|---|
| ABBV-932 | EXPERIMENTAL | Participants will receive oral ABBV-932 for a 26-week treatment period followed by a 30-day follow-up |
| ABBV-932 Dose A | EXPERIMENTAL | Participants will receive ABBV-932 dose A in addition to prescribed antidepressant therapies (ADTs). |
| ABBV-932 Dose B | EXPERIMENTAL | Participants will receive ABBV-932 dose B in addition to prescribed antidepressant therapies (ADTs). |
| Placebo for ABBV-932 | PLACEBO_COMPARATOR | Participants will receive placebo for ABBV-932 in addition to prescribed antidepressant therapies (ADTs). |
| ABBV-932 Dose C | EXPERIMENTAL | Participants will receive ABBV-932 Dose C. |
| ABBV-932 or Placebo Part A | EXPERIMENTAL | Participants will receive oral ABBV-932 or placebo once daily (QD) for 14 days. |
| ABBV-932 or Placebo Part B | EXPERIMENTAL | Participants will receive oral ABBV-932 or placebo QD for 14 days. |
| ABBV-932 or Placebo Part C | EXPERIMENTAL | Participants will receive oral ABBV-932 or placebo QD 42 days. |
| ABBV-932 with Itraconazole | EXPERIMENTAL | Participants will receive ABBV-932 in Period 1 followed by Itraconalzole in combination with ABBV-932 in Period 2. |
| ABBV-932: Arm A | EXPERIMENTAL | Participants will receive a single dose of ABBV-932 Arm A on day 1 under fasting conditions. |
| ABBV-932: Arm B | EXPERIMENTAL | Participants will receive a single dose of ABBV-932 Arm B on day 1 under fasting conditions. |
| ABBV-932: Arm C | EXPERIMENTAL | Participants will receive a single dose of ABBV-932 Arm C on day 1 under fasting conditions. |
| ABBV-932: Arm D | EXPERIMENTAL | Participants will receive a single dose of ABBV-932 Arm D on day 1 with a high-fat meal. |
| ABBV-932: Arm E | EXPERIMENTAL | Participants will receive a single dose of ABBV-932 Arm E on day 1 with a high-fat meal. |
| ABBV-932: Arm F | EXPERIMENTAL | Participants will receive a single dose of ABBV-932 Arm F on day 1 under fasting conditions. |
| ABBV-932: Arm G | EXPERIMENTAL | Participants will receive a single dose of ABBV-932 Arm G on day 1 with a high-fat meal. |
| ABBV-932: Arm H | EXPERIMENTAL | Participants will receive a single dose of ABBV-932 Arm H on day 1 under fasting conditions. |
| Part A, ABBV-932 | EXPERIMENTAL | Participants will receive ABBV-932 once daily (QD) for 14 days. |
| Part A, Placebo for ABBV-932 | EXPERIMENTAL | Participants will receive placebo for ABBV-932 QD for 14 days. |
| Part B, ABBV-932 | EXPERIMENTAL | Participants will receive ABBV-932 QD for 28 days. |
| Part B, Placebo for ABBV-932 | EXPERIMENTAL | Participants will receive placebo for ABBV-932 QD for 28 days. |
| Part C, ABBV-932 | EXPERIMENTAL | Participants will receive ABBV-932 QD for 28 days. |
| Part C, Placebo for ABBV-932 | EXPERIMENTAL | Participants will receive placebo for ABBV-932 QD for 28 days. |
| Part D, ABBV-932 | EXPERIMENTAL | Participants will receive ABBV-932 QD for 42 days. |
| Part D, Placebo for ABBV-932 | EXPERIMENTAL | Participants will receive placebo for ABBV-932 QD for 42 days. |
| Part 1: ABBV-932 | EXPERIMENTAL | Participants will receive ABBV-932 on Day 1 and followed for 30 days. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo on Day 1 and followed for 30 days. |
| 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. |
| 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. |
| Part 3: Japanese Participants: ABBV-932 | EXPERIMENTAL | Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days. |
| 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. |
| Name | Type | Description |
|---|---|---|
| ABBV-932 | DRUG | Oral Capsule |
| Placebo for ABBV-932 | DRUG | Oral Capsule |
| Antidepressant Therapy (ADT) | DRUG | Standard of care |
| Itraconazole | DRUG | Oral Capsule |
| Placebo | DRUG | Oral Capsule |
Inclusion Criteria: * Body Mass Index (BMI) \>= 18.0 to \<= 40.0 kg/m\^2, inclusive. * Participants who currently meet the Diagnostic and Statistical Manual of Mental Disorders treatment (DSM-5-TR) criteria for bipolar I or II disorder without psychotic features based on the Mini International Neur...