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
Overview
- Phase
- Phase 1
- Intervention
- ABBV-932
- Conditions
- Healthy Volunteers
- Sponsor
- AbbVie
- Enrollment
- 72
- Locations
- 3
- Primary Endpoint
- Maximum Observed Plasma Concentration (Cmax)
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
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.
Arms & Interventions
Part A, ABBV-932
Participants will receive ABBV-932 once daily (QD) for 14 days.
Intervention: ABBV-932
Part A, Placebo for ABBV-932
Participants will receive placebo for ABBV-932 QD for 14 days.
Intervention: Placebo for ABBV-932
Part B, ABBV-932
Participants will receive ABBV-932 QD for 28 days.
Intervention: ABBV-932
Part B, Placebo for ABBV-932
Participants will receive placebo for ABBV-932 QD for 28 days.
Intervention: Placebo for ABBV-932
Part C, ABBV-932
Participants will receive ABBV-932 QD for 28 days.
Intervention: ABBV-932
Part C, Placebo for ABBV-932
Participants will receive placebo for ABBV-932 QD for 28 days.
Intervention: Placebo for ABBV-932
Part D, ABBV-932
Participants will receive ABBV-932 QD for 42 days.
Intervention: ABBV-932
Part D, Placebo for ABBV-932
Participants will receive placebo for ABBV-932 QD for 42 days.
Intervention: Placebo for ABBV-932
Outcomes
Primary Outcomes
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Up to Day 28
Cmax will be assessed.
Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough)
Time Frame: Up to Day 28
Ctrough will be assessed.
Time to Cmax (Tmax)
Time Frame: 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)
Time Frame: Up to Day 28
AUCtau will be assessed.
Number of Participants with Adverse Events (AEs)
Time Frame: 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.