Healthy VolunteersPhase 1NCT07118215
A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin
A Phase 1 study testing KarXT, Midazolam and Fexofenadine in people with Healthy Volunteers, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of KarXT administration on the drug levels of midazolam, fexofenadine, and digoxin in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- KarXT, Midazolam and Fexofenadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2025to 25 Jun 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be healthy male and female (INOCBP) as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations.
- Participants must have BMI of 18.0 to 32.0 kg/m2.
Who cannot join
- Participants must not have organ dysfunction or any clinically significant deviation from normal in physical examination, VS, ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges.
- Participants must not have cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on the LFT results.
- Participants must not have any other significant acute or chronic medical illness, as assessed by the investigator.
- Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.
- Participants must not have current or recent (within 3 months of first study intervention administration) GI disease that could possibly affect drug ADME (eg, bariatric procedure).
- Participants must not have any major surgery, including GI surgery (eg, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
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- Participants must not have history of active GI obstructive disorder.
- Participants must not have history of bladder stones.
- Participants must not have history of recurrent urinary tract infections.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, 3-part, Open-label Study to Evaluate the Effects of KarXT Administration on the Pharmacokinetics of Midazolam, Fexofenadine, and Digoxin in Healthy Adult Participants
The purpose of this study is to evaluate the effects of KarXT administration on the drug levels of midazolam, fexofenadine, and digoxin in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- KarXT, Midazolam, Fexofenadine, Digoxin
- Keywords
- Healthy volunteer, Pharmacokinetics, BMS-986510, KarXT, Cobenfy, Midazolam, Fexofenadine, Digoxin, Drug-drug interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KarXTDrug
Also called BMS-986510, Xanomeline, Trospium Chloride
Specified dose on specified days
MidazolamDrug
Specified dose on specified days
FexofenadineDrug
Specified dose on specified days
DigoxinDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Not described Receives: Drug: KarXT; Drug: Midazolam |
| Part 2 | Experimental | Not described Receives: Drug: KarXT; Drug: Fexofenadine |
| Part 3 | Experimental | Not described Receives: Drug: KarXT; Drug: Digoxin |
| Part 1a | Experimental | Not described Receives: Drug: KarXT; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1/1a: Geometric mean ratio (GMR) of Maximum observed plasma concentration (Cmax) of midazolam with and without KarXT
Measured: Up to approximately day 24
Part 1/1a: GMR of Area under the plasma concentration-time curve (AUC) of midazolam with and without KarXT
Measured: Up to approximately day 24
Part 2: GMR of Cmax of fexofenadine with and without KarXT
Measured: Up to approximately day 24
Part 2: GMR of AUC of fexofenadine with and without KarXT
Measured: Up to approximately day 24
Part 3: GMR of Cmax of digoxin with and without KarXT
Measured: Up to approximately day 24
Part 3: GMR of AUC of digoxin with and without KarXT
Measured: Up to approximately day 24
Secondary outcomes (8)
Number of participants with adverse events (AEs)
Measured: Up to approximately day 47
Number of participants with serious adverse events (SAEs)
Measured: Up to approximately day 47
Number of participants with physical examination abnormalities
Measured: Up to approximately day 24
Number of participants with vital sign abnormalities
Measured: Up to approximately day 24
Number of participants with 12-lead electrocardiogram abnormalities (ECGs)
Measured: Up to approximately day 24
Number of participants with clinical laboratory assessment abnormalities
Measured: Up to approximately day 24
Number of participants with suicidal ideation with the use of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to approximately day 24
Number of participants with adverse event of special interest (AESIs)
Measured: Up to approximately day 47
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start29 Sep 2025
- Primary completion25 Jun 2026
- Study completion25 Jun 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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118215
- Sponsor's protocol ID
- CN012-0013
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 3-part, Open-label Study to Evaluate the Effects of KarXT Administration on the Pharmacokinetics of Midazolam, Fexofenadine, and Digoxin in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07118215
- Acronym / sponsor ID
- CN012-0013
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteer, Pharmacokinetics, BMS-986510, KarXT, Cobenfy, Midazolam, Fexofenadine, Digoxin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb companyIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 12 Aug 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 purpose of this study is to evaluate the effects of KarXT administration on the drug levels of midazolam, fexofenadine, and digoxin in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: KarXT, Drug: Midazolam |
| Part 2 | Experimental | Drug: KarXT, Drug: Fexofenadine |
| Part 3 | Experimental | Drug: KarXT, Drug: Digoxin |
| Part 1a | Experimental | Drug: KarXT, Drug: Midazolam |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants must be healthy male and female (INOCBP) as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations.
- Participants must have BMI of 18.0 to 32.0 kg/m2.
Key exclusion criteria (10 listed)
- Participants must not have organ dysfunction or any clinically significant deviation from normal in physical examination, VS, ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges.
- Participants must not have cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on the LFT results.
- Participants must not have any other significant acute or chronic medical illness, as assessed by the investigator.
- Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.
- Participants must not have current or recent (within 3 months of first study intervention administration) GI disease that could possibly affect drug ADME (eg, bariatric procedure).
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 |
|---|---|---|
| KarXTAlso: BMS-986510, Xanomeline, Trospium ChlorideSpecified dose on specified days | Drug | Part 1, Part 1a, Part 2, Part 3 |
| MidazolamSpecified dose on specified days | Drug | Part 1, Part 1a |
| FexofenadineSpecified dose on specified days | Drug | Part 2 |
| DigoxinSpecified dose on specified days | Drug | Part 3 |
Primary outcome
Part 1/1a: Geometric mean ratio (GMR) of Maximum observed plasma concentration (Cmax) of midazolam with and without KarXT
Time frame: Up to approximately day 24
Part 1/1a: GMR of Area under the plasma concentration-time curve (AUC) of midazolam with and without KarXT
Time frame: Up to approximately day 24
Part 2: GMR of Cmax of fexofenadine with and without KarXT
Time frame: Up to approximately day 24
Part 2: GMR of AUC of fexofenadine with and without KarXT
Time frame: Up to approximately day 24
Part 3: GMR of Cmax of digoxin with and without KarXT
Time frame: Up to approximately day 24
Part 3: GMR of AUC of digoxin with and without KarXT
Time frame: Up to approximately day 24
8 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to approximately day 47
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately day 47
Number of participants with physical examination abnormalities
Time frame: Up to approximately day 24
Number of participants with vital sign abnormalities
Time frame: Up to approximately day 24
Number of participants with 12-lead electrocardiogram abnormalities (ECGs)
Time frame: Up to approximately day 24
Number of participants with clinical laboratory assessment abnormalities
Time frame: Up to approximately day 24
Number of participants with suicidal ideation with the use of the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately day 24
Number of participants with adverse event of special interest (AESIs)
Time frame: Up to approximately day 47
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 22 Jul 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 KarXT, Midazolam and Fexofenadine in people with Healthy Volunteers, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company 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 10 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 22 Jul 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?
Part 1/1a: Geometric mean ratio (GMR) of Maximum observed plasma concentration (Cmax) of midazolam with and without KarXT (time frame: Up to approximately day 24). The study lists 6 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 22 Jul 2026.