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
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