Study to Assess Adverse Events and How ABBV-932 Oral Capsules Moves Through the Body of Healthy Adult Participants

Study Overview
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Brief Summary
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The main objective of this study is to assess pharmacokinetics, safety, and tolerability of ABBV-932 in healthy adult participants.

Official Title
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Generalized Anxiety Disorder (GAD): A First-in-Human Single Ascending Dose and Food Effect Study of ABBV-932 in Healthy Adult Subjects

Conditions
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Generalized Anxiety Disorder (GAD), Healthy Participants

Intervention / Treatment
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* Drug: ABBV-932
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parts 1 and 2: Healthy individuals with body-mass index (BMI) >= 18.0 to <= 32.0 kg/m2, rounded to the tenths decimal. Part 3: Healthy Japanese, Han Chinese individuals with BMI >= 18.0 to <= 30.0 kg/m2, rounded to the tenths decimal. Condition of general good health based upon the results of a medical history, physical examination, vital signs, laboratory profile, neurological examination, and a 12-lead ECG. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: ABBV-932<br>Participants will receive ABBV-932 on Day 1 and followed for 30 days. | Drug: ABBV-932<br>* Oral Capsule<br>|
| Placebo Comparator: Part 1: Placebo<br>Participants will receive placebo on Day 1 and followed for 30 days. | Drug: Placebo<br>* Oral Capsule<br>|
| Experimental: Part 2: Sequence 1<br>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. | Drug: ABBV-932<br>* Oral Capsule<br>|
| Experimental: Part 2: Sequence 2<br>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. | Drug: ABBV-932<br>* Oral Capsule<br>|
| Experimental: Part 3: Japanese Participants: ABBV-932<br>Japanese participants will receive ABBV-932 on Day 1 in Period 1 and followed for 30 days. | Drug: ABBV-932<br>* Oral Capsule<br>|
| Placebo Comparator: Part 3: Japanese Participants: Placebo<br>Japanese participants will receive placebo on Day 1 in Period 1 and followed for 30 days. | Drug: Placebo<br>* Oral Capsule<br>|
| Experimental: Part 3: Han-Chinese Participants: ABBV-932<br>Han-Chinese participants will receive placebo on Day 1 in Period 1 and followed for 30 days. | Drug: ABBV-932<br>* Oral Capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized Anxiety Disorder (GAD), ABBV-932