A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Participants, Participants With Generalized Anxiety Disorder (GAD) and Participants With Bipolar Disorder (BPD)
- Conditions
- Generalized Anxiety Disorder (GAD)Bipolar Disorder (BPD)Healthy Volunteers
- Interventions
- Drug: Placebo for ABBV-932
- Registration Number
- NCT06024239
- Lead Sponsor
- AbbVie
- Brief Summary
The purpose of this study is to assess the pharmacokinetics, safety, and tolerability following multiple ascending oral doses of ABBV-932 or placebo in healthy adult participants, participants with Generalized Anxiety Disorder (GAD), and participants with bipolar disorder (BPD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
-
For healthy volunteer cohort:
-- Body mass index (BMI) is >= 18.0 to <= 32.0 kg/m2 after rounding to the tenths decimal.
-
For participants with generalized anxiety disorder (GAD) or bipolar disorder (BPD)
- Participants with GAD or BPD (as confirmed by MINI) meet participant psychiatric history criteria described in the protocol.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part D, Placebo for ABBV-932 Placebo for ABBV-932 Participants will receive placebo for ABBV-932 QD for 42 days. Part A, Placebo for ABBV-932 Placebo for ABBV-932 Participants will receive placebo for ABBV-932 QD for 14 days. Part C, Placebo for ABBV-932 Placebo for ABBV-932 Participants will receive placebo for ABBV-932 QD for 28 days. Part D, ABBV-932 ABBV-932 Participants will receive ABBV-932 QD for 42 days. Part B, ABBV-932 ABBV-932 Participants will receive ABBV-932 QD for 28 days. Part A, ABBV-932 ABBV-932 Participants will receive ABBV-932 once daily (QD) for 14 days. Part B, Placebo for ABBV-932 Placebo for ABBV-932 Participants will receive placebo for ABBV-932 QD for 28 days. Part C, ABBV-932 ABBV-932 Participants will receive ABBV-932 QD for 28 days.
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) Up to Day 28 Cmax will be assessed.
Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough) Up to Day 28 Ctrough will be assessed.
Time to Cmax (Tmax) Up to Day 28 Tmax will be assessed.
Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) Up to Day 28 AUCtau will be assessed.
Number of Participants with Adverse Events (AEs) Baseline to Day 129 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Collaborative Neuroscience Research CNS /ID# 260270
🇺🇸Los Alamitos, California, United States
Acpru /Id# 255945
🇺🇸Grayslake, Illinois, United States
Hassman Research Institute Marlton Site /ID# 260271
🇺🇸Marlton, New Jersey, United States