A Multiple Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Subjects, Subjects With Generalized Anxiety Disorder (GAD) and Subjects With Bipolar Disorder
Status: Completed
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• 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.
Locations
United States
California
Collaborative Neuroscience Research CNS /ID# 260270
Los Alamitos
Illinois
Acpru /Id# 255945
Grayslake
New Jersey
Hassman Research Institute Marlton Site /ID# 260271
Marlton
Time Frame
Start Date: 2023-08-31
Completion Date: 2025-03-04
Participants
Target number of participants: 72
Treatments
Experimental: Part A, ABBV-932
Participants will receive ABBV-932 once daily (QD) for 14 days.
Experimental: Part A, Placebo for ABBV-932
Participants will receive placebo for ABBV-932 QD for 14 days.
Experimental: Part B, ABBV-932
Participants will receive ABBV-932 QD for 28 days.
Experimental: Part B, Placebo for ABBV-932
Participants will receive placebo for ABBV-932 QD for 28 days.
Experimental: Part C, ABBV-932
Participants will receive ABBV-932 QD for 28 days.
Experimental: Part C, Placebo for ABBV-932
Participants will receive placebo for ABBV-932 QD for 28 days.
Experimental: Part D, ABBV-932
Participants will receive ABBV-932 QD for 42 days.
Experimental: Part D, Placebo for ABBV-932
Participants will receive placebo for ABBV-932 QD for 42 days.
Related Therapeutic Areas
Sponsors
Leads: AbbVie