Healthy VolunteerPhase 1NCT07219017
A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants
A Phase 1 study testing ABBV-1354 in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial summary
This study is to assess the mass balance of oral ABBV-1354 in healthy adult male participants. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ABBV-1354
- 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 siteUnited States
- Study dates
- 15 Oct 2025to 9 Dec 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male participants are eligible to participate if they agree to the following from Study Day 1 and for at least 93 days after the last dose of study treatment:
- Refrain from donating sperm
- PLUS, either:
- Practice true abstinence, defined as: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable.
- OR
- Use a male condom with spermicide (even with a successful vasectomy) with female partner who also uses a highly effective contraceptive method with a failure rate of < 1% per year (when used consistently and correctly).
Show all 10Show fewer
- AND
- Advise of the benefit for a female partner to use a highly effective method of contraception (as a condom may break or leak) if having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
- BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
Who cannot join
- History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Inc /ID# 277011
Madison, Wisconsin, 53704
About this study
Official title: Mass Balance Study of [14C] ABBV-1354 (Icalcaprant) in Healthy Male Subjects Following Single Oral Dose Administration
This study is to assess the mass balance of oral ABBV-1354 in healthy adult male participants.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-1354
- Keywords
- Healthy Volunteer, ABBV-1354
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-1354Drug
Oral solution
| Study group | Role | What they receive |
|---|---|---|
| ABBV-1354 | Experimental | Participants will receive a single dose of oral ABBV-1354 and followed 30 days post dose. Receives: Drug: ABBV-1354 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Up to approximately 32 days
Number of Participants with Abnormal Change from Baseline in Vital Sign Measurements
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Measured: Up to approximately 15 days
Change From Baseline in Electrocardiograms (ECGs)
12-lead resting ECG will be recorded.
Measured: Up to approximately 15 days
Number of Participants with Abnormal Change in Physical Examinations
Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.
Measured: Up to approximately 15 days
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Measured: Up to approximately 15 days
Maximum observed concentration (Cmax) of ABBV-1354
Cmax of ABBV-1354 will be assessed.
Measured: Up to approximately 15 days
Time to Cmax (peak time, Tmax) of ABBV-1354
Max of ABBV-1354 will be assessed.
Measured: Up to approximately 15 days
Terminal phase elimination half-life (t1/2) of ABBV-1354
Terminal phase elimination half-life (t1/2) of ABBV-1354 will be assessed.
Measured: Up to approximately 15 days
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-1354
AUCt of ABBV-1354 will be assessed.
Measured: Up to approximately 15 days
Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-1354
AUCinf of ABBV-1354 will be assessed.
Measured: Up to approximately 15 days
Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu)
Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu) will be assessed.
Measured: Up to approximately 15 days
Percent of ABBV-1354 excreted in the urine
Percent excreted = 100 × (Aeu/dose).
Measured: Up to approximately 15 days
Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu)
Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu) will be assessed.
Measured: Up to approximately 15 days
Percent of ABBV-1354 radioactivity excreted in the feces
Percent excreted = 100 × (Aeu/dose).
Measured: Up to approximately 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start15 Oct 2025
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
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
- NCT07219017
- Sponsor's protocol ID
- M25-571
- Status last verified
- Dec 2025
- First submitted
- 17 Oct 2025
- Last updated
- 5 Jan 2026
- 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Balance Study of [14C] ABBV-1354 (Icalcaprant) in Healthy Male Subjects Following Single Oral Dose Administration
- ClinicalTrials.gov ID
- NCT07219017
- Acronym / sponsor ID
- M25-571
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-1354
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 21 Oct 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.
This study is to assess the mass balance of oral ABBV-1354 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-1354 | Experimental | Drug: ABBV-1354Participants will receive a single dose of oral ABBV-1354 and followed 30 days post dose. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male participants are eligible to participate if they agree to the following from Study Day 1 and for at least 93 days after the last dose of study treatment:
- Refrain from donating sperm
- Practice true abstinence, defined as: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable.
- OR
- Use a male condom with spermicide (even with a successful vasectomy) with female partner who also uses a highly effective contraceptive method with a failure rate of < 1% per year (when used consistently and correctly).
Key exclusion criteria (3 listed)
- History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
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-1354Oral solution | Drug | ABBV-1354 |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 32 days
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.
Number of Participants with Abnormal Change from Baseline in Vital Sign Measurements
Time frame: Up to approximately 15 days
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Change From Baseline in Electrocardiograms (ECGs)
Time frame: Up to approximately 15 days
12-lead resting ECG will be recorded.
Number of Participants with Abnormal Change in Physical Examinations
Time frame: Up to approximately 15 days
Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, gastrointestinal, and neurological systems will be assessed.
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Time frame: Up to approximately 15 days
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Maximum observed concentration (Cmax) of ABBV-1354
Time frame: Up to approximately 15 days
Cmax of ABBV-1354 will be assessed.
Time to Cmax (peak time, Tmax) of ABBV-1354
Time frame: Up to approximately 15 days
Max of ABBV-1354 will be assessed.
Terminal phase elimination half-life (t1/2) of ABBV-1354
Time frame: Up to approximately 15 days
Terminal phase elimination half-life (t1/2) of ABBV-1354 will be assessed.
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-1354
Time frame: Up to approximately 15 days
AUCt of ABBV-1354 will be assessed.
Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-1354
Time frame: Up to approximately 15 days
AUCinf of ABBV-1354 will be assessed.
Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu)
Time frame: Up to approximately 15 days
Amount of ABBV-1354 excreted in the urine over the sampling period (Aeu) will be assessed.
Percent of ABBV-1354 excreted in the urine
Time frame: Up to approximately 15 days
Percent excreted = 100 × (Aeu/dose).
Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu)
Time frame: Up to approximately 15 days
Amount of ABBV-1354 excreted in the feces over the sampling period (Aeu) will be assessed.
Percent of ABBV-1354 radioactivity excreted in the feces
Time frame: Up to approximately 15 days
Percent excreted = 100 × (Aeu/dose).
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 5 Jan 2026.
- 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
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-1354 in people with Healthy Volunteer, run by AbbVie at 1 site 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 10 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 5 Jan 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 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?
Number of Participants with Adverse Events (AEs) (time frame: Up to approximately 32 days). The study lists 14 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 5 Jan 2026.