Healthy VolunteersPhase 1MADNCT06024239
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)
A Phase 1 study testing ABBV-932 in people with Healthy Volunteers and Generalized Anxiety Disorder (GAD), run by AbbVie at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Generalized Anxiety Disorder (GAD), Bipolar Disorder (BPD)
- What is being tested?
- ABBV-932
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Aug 2023to 4 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Acpru /Id# 255945
Grayslake, Illinois, 60030
Collaborative Neuroscience Research CNS /ID# 260270
Los Alamitos, California, 90720
Hassman Research Institute Marlton Site /ID# 260271
Marlton, New Jersey, 08053
About this study
Official title: 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
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).
- Being tested
- ABBV-932, Placebo for ABBV-932
- Keywords
- ABBV-932, Generalized Anxiety Disorder (GAD), Bipolar Disorder (BPD)
- Medical subject headings
- Generalized Anxiety Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-932Drug
Capsule; oral
Placebo for ABBV-932Drug
Capsule; oral
| Study group | Role | What they receive |
|---|---|---|
| Part A, ABBV-932 | Experimental | Participants will receive ABBV-932 once daily (QD) for 14 days. Receives: Drug: ABBV-932 |
| Part A, Placebo for ABBV-932 | Experimental | Participants will receive placebo for ABBV-932 QD for 14 days. Receives: Drug: Placebo for ABBV-932 |
| Part B, ABBV-932 | Experimental | Participants will receive ABBV-932 QD for 28 days. Receives: Drug: ABBV-932 |
| Part B, Placebo for ABBV-932 | Experimental | Participants will receive placebo for ABBV-932 QD for 28 days. Receives: Drug: Placebo for ABBV-932 |
| Part C, ABBV-932 | Experimental | Participants will receive ABBV-932 QD for 28 days. Receives: Drug: ABBV-932 |
| Part C, Placebo for ABBV-932 | Experimental | Participants will receive placebo for ABBV-932 QD for 28 days. Receives: Drug: Placebo for ABBV-932 |
| Part D, ABBV-932 | Experimental | Participants will receive ABBV-932 QD for 42 days. Receives: Drug: ABBV-932 |
| Part D, Placebo for ABBV-932 | Experimental | Participants will receive placebo for ABBV-932 QD for 42 days. Receives: Drug: Placebo for ABBV-932 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Cmax will be assessed.
Measured: Up to Day 28
Time to Cmax (Tmax)
Tmax will be assessed.
Measured: Up to Day 28
Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough)
Ctrough will be assessed.
Measured: Up to Day 28
Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau)
AUCtau will be assessed.
Measured: Up to Day 28
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.
Measured: Baseline to Day 129
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start31 Aug 2023
- Primary completion4 Mar 2025
- Study completion4 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024239
- Sponsor's protocol ID
- M23-893
- Acronym
- MAD
- Status last verified
- Mar 2025
- First submitted
- 30 Aug 2023
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06024239
- Acronym / sponsor ID
- MAD / M23-893
- Keywords
- ABBV-932, Generalized Anxiety Disorder (GAD), Bipolar Disorder (BPD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part A, ABBV-932 | Experimental | Drug: ABBV-932Participants will receive ABBV-932 once daily (QD) for 14 days. |
| Part A, Placebo for ABBV-932 | Experimental | Drug: Placebo for ABBV-932Participants will receive placebo for ABBV-932 QD for 14 days. |
| Part B, ABBV-932 | Experimental | Drug: ABBV-932Participants will receive ABBV-932 QD for 28 days. |
| Part B, Placebo for ABBV-932 | Experimental | Drug: Placebo for ABBV-932Participants will receive placebo for ABBV-932 QD for 28 days. |
| Part C, ABBV-932 | Experimental | Drug: ABBV-932Participants will receive ABBV-932 QD for 28 days. |
| Part C, Placebo for ABBV-932 | Experimental | Drug: Placebo for ABBV-932Participants will receive placebo for ABBV-932 QD for 28 days. |
| Part D, ABBV-932 | Experimental | Drug: ABBV-932Participants will receive ABBV-932 QD for 42 days. |
| Part D, Placebo for ABBV-932 | Experimental | Drug: Placebo for ABBV-932Participants will receive placebo for ABBV-932 QD for 42 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-932Capsule; oral | Drug | Part A, ABBV-932, Part B, ABBV-932, Part C, ABBV-932, Part D, ABBV-932 |
| Placebo for ABBV-932Capsule; oral | Drug | Part A, Placebo for ABBV-932, Part B, Placebo for ABBV-932, Part C, Placebo for ABBV-932, Part D, Placebo for ABBV-932 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Day 28
Cmax will be assessed.
Time to Cmax (Tmax)
Time frame: Up to Day 28
Tmax 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-932 in people with Healthy Volunteers and Generalized Anxiety Disorder (GAD), run by AbbVie at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: Up to Day 28). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.