Healthy Volunteers Clinical Trial
Official title:
A Multiple Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Subjects, Patients With Generalized Anxiety Disorder (GAD) and Patients With Bipolar Disorder (BPD)
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).
| Status | Recruiting |
| Enrollment | 64 |
| Est. completion date | November 21, 2024 |
| Est. primary completion date | November 21, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Months to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Acpru /Id# 255945 | Grayslake | Illinois |
| United States | Cenexel CNS /ID# 260270 | Los Alamitos | California |
| United States | CenExel HRI /ID# 260271 | Marlton | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) | Cmax will be assessed. | Up to Day 28 | |
| Primary | Time to Cmax (Tmax) | Tmax will be assessed. | Up to Day 28 | |
| Primary | Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough) | Ctrough will be assessed. | Up to Day 28 | |
| Primary | Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) | AUCtau will be assessed. | Up to Day 28 | |
| Primary | Number of Participants with Adverse Events (AEs) | 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. | Baseline to Day 129 |
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