Healthy VolunteerPhase 1NCT06953934
A Mass Balance Study of Oral [14C] ABBV-932 in Healthy Adult Male Participants
A Phase 1 study testing ABBV-932 in people with Healthy Volunteer, run by AbbVie at 1 site in Netherlands.
Trial summary
The main objective of this study is to assess the safety and tolerability of ABBV-932 in healthy adult male participants. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ABBV-932
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 May 2026to 14 Sep 2026
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) ≥ 18.0 to ≤ 29.9.0 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Male participant who is not considering fathering a child or donating sperm during the study and for 100 days after the study drug administration
- A condition of general good health, based upon the results of a medical history, physical exam
Who cannot join
- Has not participated in another [14C] absorption, distribution, metabolism, excretion (ADME) study with a radiodose above 0.1 MBq in the period of 12 months prior to screening.
- Use of any medications/products known to alter drug absorption, metabolism, or excretion processes, within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration.
- Prior exposure to ABBV-932 or cariprazine within the past 90 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mass Balance Study of [14C] ABBV-932 Following Single Oral Dose Administration in Healthy Male Volunteers
The main objective of this study is to assess the safety and tolerability of ABBV-932 in healthy adult male participants.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-932
- Keywords
- Healthy Volunteer, ABBV-932
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-932Drug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| ABBV-932 | Experimental | Participants will receive a single oral dose of ABBV-932 on day 1. Receives: Drug: ABBV-932 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of ABBV-932
Cmax of ABBV-932
Measured: Up to approximately 86 days
Time to Cmax (Tmax) of ABBV-932
Tmax of ABBV-932
Measured: Up to approximately 86 days
Terminal phase elimination rate constant (λz) of ABBV-932
Terminal phase elimination rate constant (λz) of ABBV-932
Measured: Up to approximately 86 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-932
Terminal phase elimination half-life of ABBV-932
Measured: Up to approximately 86 days
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932
AUCt of ABBV-932
Measured: Up to approximately 86 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932
AUCinf of ABBV-932
Measured: Up to approximately 86 days
Number of Participants Experiencing Adverse Events
An 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: Up to approximately 103 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start4 May 2026
- Primary completion14 Sep 2026
- Study completion14 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT06953934
- Sponsor's protocol ID
- M24-991
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Balance Study of [14C] ABBV-932 Following Single Oral Dose Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT06953934
- Acronym / sponsor ID
- M24-991
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-932
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 4 May 2026 (actual)
- Primary completion
- 14 Sep 2026 (actual)
- Study completion
- 14 Sep 2026 (actual)
- First posted
- 1 May 2025 (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 main objective of this study is to assess the safety and tolerability of ABBV-932 in healthy adult male participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABBV-932 | Experimental | Drug: ABBV-932Participants will receive a single oral dose of ABBV-932 on day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) ≥ 18.0 to ≤ 29.9.0 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Male participant who is not considering fathering a child or donating sperm during the study and for 100 days after the study drug administration
- A condition of general good health, based upon the results of a medical history, physical exam
Key exclusion criteria (3 listed)
- Has not participated in another [14C] absorption, distribution, metabolism, excretion (ADME) study with a radiodose above 0.1 MBq in the period of 12 months prior to screening.
- Use of any medications/products known to alter drug absorption, metabolism, or excretion processes, within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration.
- Prior exposure to ABBV-932 or cariprazine within the past 90 days.
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-932Oral Capsule | Drug | ABBV-932 |
Primary outcome
Maximum Plasma Concentration (Cmax) of ABBV-932
Time frame: Up to approximately 86 days
Cmax of ABBV-932
Time to Cmax (Tmax) of ABBV-932
Time frame: Up to approximately 86 days
Tmax of ABBV-932
Terminal phase elimination rate constant (λz) of ABBV-932
Time frame: Up to approximately 86 days
Terminal phase elimination rate constant (λz) of ABBV-932
Terminal Phase Elimination Half-Life (t1/2) of ABBV-932
Time frame: Up to approximately 86 days
Terminal phase elimination half-life of ABBV-932
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-932
Time frame: Up to approximately 86 days
AUCt of ABBV-932
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-932
Time frame: Up to approximately 86 days
AUCinf of ABBV-932
Number of Participants Experiencing Adverse Events
Time frame: Up to approximately 103 days
An 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 13 Oct 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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
1 site 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 Volunteer, run by AbbVie at 1 site in Netherlands.
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 3 inclusion and 3 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 Plasma Concentration (Cmax) of ABBV-932 (time frame: Up to approximately 86 days). The study lists 7 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 13 Oct 2026.