Healthy VolunteersPhase 1NCT07587008
Study to Assess Adverse Events and How Oral Emraclidine Moves Through the Body of Adult Healthy Volunteers
A Phase 1 study testing Emraclidine in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial summary
The objective of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of emraclidine following single oral administration of different immediate-release (IR) tablet formulations in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Emraclidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2026to 17 Jul 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index of 18.5 to 32.0 kg/m2, inclusive.
- Total body weight >= 50 kg.
Who cannot join
- History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement.
- Vital sign measurements, at Screening and Check-in:
- Systolic blood pressure >= 140 mmHg or < 100 mmHg
- Diastolic blood pressure >= 90 mmHg or < 60 mmHg
- Heart rate > 100 bpm or < 50 bpm
- Orthostatic hypotension, defined as a decrease of >= 20 mmHg in systolic blood pressure upon standing compared with the supine/sitting blood pressure measurement.
- Female participants of childbearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Single Dose, Crossover Study to Assess the Relative Bioavailability of Emraclidine Formulations in Healthy Adult Subjects
The objective of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of emraclidine following single oral administration of different immediate-release (IR) tablet formulations in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- Emraclidine
- Keywords
- Healthy Volunteers, Emraclidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmraclidineDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants will receive Emraclidine in 3 different formulations in Sequence 1. Receives: Drug: Emraclidine |
| Sequence 2 | Experimental | Participants will receive Emraclidine in 3 different formulations in Sequence 2. Receives: Drug: Emraclidine |
| Sequence 3 | Experimental | Participants will receive Emraclidine in 3 different formulations in Sequence 3. Receives: Drug: Emraclidine |
| Sequence 4 | Experimental | Participants will receive Emraclidine in 3 different formulations in Sequence 4. Receives: Drug: Emraclidine |
| Sequence 5 | Experimental | Participants will receive Emraclidine in 3 different formulations in Sequence 5. Receives: Drug: Emraclidine |
| Sequence 6 | Experimental | Participants will receive Emraclidine in 3 different formulations in Sequence 6. Receives: Drug: Emraclidine |
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. The investigator assesses the relationship of each event to the use of study.
Measured: Up to approximately 44 days
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Cmax of Emraclidine.
Measured: Up to approximately 14 days
Time to Cmax (Tmax) of Emraclidine
Tmax of Emraclidine.
Measured: Up to approximately 14 days
Area Under the Concentration-Time Curve from Time 0 to Time t (AUC) of Emraclidine
AUC of Emraclidine.
Measured: Up to approximately 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start12 May 2026
- Primary completion17 Jul 2026
- Study completion17 Jul 2026
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT07587008
- Sponsor's protocol ID
- M26-506
- Status last verified
- Aug 2026
- First submitted
- 8 May 2026
- Last updated
- 14 Aug 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 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single Dose, Crossover Study to Assess the Relative Bioavailability of Emraclidine Formulations in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07587008
- Acronym / sponsor ID
- M26-506
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, Emraclidine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 12 May 2026 (actual)
- Primary completion
- 17 Jul 2026 (actual)
- Study completion
- 17 Jul 2026 (actual)
- First posted
- 14 May 2026 (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 objective of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of emraclidine following single oral administration of different immediate-release (IR) tablet formulations in healthy adult participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: EmraclidineParticipants will receive Emraclidine in 3 different formulations in Sequence 1. |
| Sequence 2 | Experimental | Drug: EmraclidineParticipants will receive Emraclidine in 3 different formulations in Sequence 2. |
| Sequence 3 | Experimental | Drug: EmraclidineParticipants will receive Emraclidine in 3 different formulations in Sequence 3. |
| Sequence 4 | Experimental | Drug: EmraclidineParticipants will receive Emraclidine in 3 different formulations in Sequence 4. |
| Sequence 5 | Experimental | Drug: EmraclidineParticipants will receive Emraclidine in 3 different formulations in Sequence 5. |
| Sequence 6 | Experimental | Drug: EmraclidineParticipants will receive Emraclidine in 3 different formulations in Sequence 6. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index of 18.5 to 32.0 kg/m2, inclusive.
- Total body weight >= 50 kg.
Key exclusion criteria (7 listed)
- History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement.
- Vital sign measurements, at Screening and Check-in:
- Female participants of childbearing potential
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 |
|---|---|---|
| EmraclidineOral tablet | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 44 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. The investigator assesses the relationship of each event to the use of study.
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Time frame: Up to approximately 14 days
Cmax of Emraclidine.
Time to Cmax (Tmax) of Emraclidine
Time frame: Up to approximately 14 days
Tmax of Emraclidine.
Area Under the Concentration-Time Curve from Time 0 to Time t (AUC) of Emraclidine
Time frame: Up to approximately 14 days
AUC of Emraclidine.
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 14 Aug 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 Emraclidine in people with Healthy Volunteers, 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 2 inclusion and 7 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 14 Aug 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 44 days). The study lists 4 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 14 Aug 2026.