HealthyPhase 1NCT07862621
A Clinical Trial of MK-6916 With Midazolam and Rosuvastatin in Healthy Participants (MK-6916-012)
A Phase 1 study testing Midazolam, Rosuvastatin and MK-6916 in people with Healthy, run by Merck Sharp & Dohme LLC.
Trial summary
Researchers are looking for new treatments for pain. The goal of this trial is to learn if MK-6916 changes what happens to the midazolam and rosuvastatin in healthy participants' bodies. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Midazolam, Rosuvastatin and MK-6916
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 19 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Is in good health
- Has a body mass index between 18 and 32 kg/m^2, inclusive
Who cannot join
- Has history of cancer (malignancy)
- Has positive test(s) for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus
About this study
Official title: A 2-period Study to Evaluate the Effects of Multiple Oral Doses of MK-6916 on the Single-dose Pharmacokinetics of Midazolam and Rosuvastatin
Researchers are looking for new treatments for pain. The goal of this trial is to learn if MK-6916 changes what happens to the midazolam and rosuvastatin in healthy participants' bodies. Researchers will compare the amount of midazolam and rosuvastatin in a participant's body over time when they are given with and without MK-6916.
- Conditions
- Healthy
- Being tested
- Midazolam, Rosuvastatin, MK-6916
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Administered orally on Day 1 of Period 1 and on Days 2 and 14 of Period 2.
RosuvastatinDrug
Administered orally on Day 1 of Period 1 and Day 14 of Period 2.
MK-6916Drug
Administered orally once every 12 hours on Days 1 through 18 in Period 2.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam + Rosuvastatin + MK-6916 | Experimental | In Period 1, participants will receive midazolam and rosuvastatin. In Period 2, participants will receive MK-6916, midazolam, and rosuvastatin. Receives: Drug: Midazolam; Drug: Rosuvastatin; Drug: MK-6916 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Period 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam.
Measured: Predose and at designated timepoints up to approximately 24 hours
Period 2: AUC0-inf of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam.
Measured: Predose and at designated timepoints up to approximately Day 15
Period 1: AUC0-inf of Rosuvastatin
Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin.
Measured: Predose and at designated timepoints up to approximately 96 hours
Period 2: AUC0-inf of Rosuvastatin
Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin.
Measured: Predose and at designated timepoints up to approximately Day 19
Secondary outcomes (42)
Period 1: AUC0-inf of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam metabolite (1-hydroxymidazolam).
Measured: Predose and at designated timepoints up to approximately 24 hours
Period 2: AUC0-inf of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam metabolite (1-hydroxymidazolam).
Measured: Predose and at designated timepoints up to approximately Day 15
Period 1: Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-last of midazolam.
Measured: Predose and at designated timepoints up to approximately 24 hours
Period 2: AUC0-last of Midazolam
Blood samples will be collected at multiple time points to determine the AUC0-last of midazolam.
Measured: Predose and at designated timepoints up to approximately Day 15
Period 1: AUC0-last of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the AUC0-last of midazolam metabolite (1-hydroxymidazolam).
Measured: Predose and at designated timepoints up to approximately 24 hours
Period 2: AUC0-last of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the AUC0-last of midazolam metabolite (1-hydroxymidazolam).
Measured: Predose and at designated timepoints up to approximately Day 15
Period 1: Maximum Plasma Concentration (Cmax) of Midazolam
Blood samples will be collected at multiple time points to determine the Cmax of midazolam.
Measured: Predose and at designated timepoints up to approximately 24 hours
Period 2: Cmax of Midazolam
Blood samples will be collected at multiple time points to determine the Cmax of midazolam.
Measured: Predose and at designated timepoints up to approximately Day 15
Period 1: Cmax of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the Cmax of midazolam metabolite (1-hydroxymidazolam).
Measured: Predose and at designated timepoints up to approximately 24 hours
Period 2: Cmax of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the Cmax of midazolam metabolite (1-hydroxymidazolam).
Measured: Predose and at designated timepoints up to approximately Day 15
Period 1: Time to Maximum Plasma Concentration (Tmax) of Midazolam
Blood samples will be collected at multiple time points to determine the Tmax of midazolam.
Measured: Predose and at designated timepoints up to approximately 24 hours
Period 2: Tmax of Midazolam
Blood samples will be collected at multiple time points to determine the Tmax of midazolam.
Measured: Predose and at designated timepoints up to approximately Day 15
Period 1: Tmax of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the Tmax of midazolam metabolite (1-hydroxymidazolam).
Measured: Predose and at designated timepoints up to approximately 24 hours
Period 2: Tmax of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the Tmax of midazolam metabolite (1-hydroxymidazolam).
Measured: Predose and at designated timepoints up to approximately Day 15
Period 1: Apparent Terminal Half-life (t1/2) of Midazolam
Blood samples will be collected at multiple time points to determine the t1/2 of midazolam.
Measured: Predose and at designated timepoints up to approximately 24 hours
Period 2: t1/2 of Midazolam
Blood samples will be collected at multiple time points to determine the t1/2 of midazolam.
Measured: Predose and at designated timepoints up to approximately Day 15
Period 1: t1/2 of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the t1/2 of midazolam metabolite (1-hydroxymidazolam).
Measured: Predose and at designated timepoints up to approximately 24 hours
Period 2: t1/2 of Midazolam Metabolite (1-Hydroxymidazolam)
Blood samples will be collected at multiple time points to determine the t1/2 of midazolam metabolite (1-hydroxymidazolam).
Measured: Predose and at designated timepoints up to approximately Day 15
Period 1: Apparent Clearance (CL/F) of Midazolam
Blood samples will be collected at multiple time points to determine the CL/F of midazolam.
Measured: Predose and at designated timepoints up to approximately 24 hours
Period 2: CL/F of Midazolam
Blood samples will be collected at multiple time points to determine the CL/F of midazolam.
Measured: Predose and at designated timepoints up to approximately Day 15
Period 1: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam
Blood samples will be collected at multiple time points to determine the Vz/F of midazolam.
Measured: Predose and at designated timepoints up to approximately 24 hours
Period 2: Vz/F of Midazolam
Blood samples will be collected at multiple time points to determine the Vz/F of midazolam.
Measured: Predose and at designated timepoints up to approximately Day 15
Period 1: AUC0-last of Rosuvastatin
Blood samples will be collected at multiple time points to determine the AUC0-last of rosuvastatin.
Measured: Predose and at designated timepoints up to approximately 96 hours
Period 2: AUC0-last of Rosuvastatin
Blood samples will be collected at multiple time points to determine the AUC0-last of rosuvastatin.
Measured: Predose and at designated timepoints up to approximately Day 19
Period 1: Cmax of Rosuvastatin
Blood samples will be collected at multiple time points to determine the Cmax of rosuvastatin.
Measured: Predose and at designated timepoints up to approximately 96 hours
Period 2: Cmax of Rosuvastatin
Blood samples will be collected at multiple time points to determine the Cmax of rosuvastatin.
Measured: Predose and at designated timepoints up to approximately Day 19
Period 1: Tmax of Rosuvastatin
Blood samples will be collected at multiple time points to determine the Tmax of rosuvastatin.
Measured: Predose and at designated timepoints up to approximately 96 hours
Period 2: Tmax of Rosuvastatin
Blood samples will be collected at multiple time points to determine the Tmax of rosuvastatin.
Measured: Predose and at designated timepoints up to approximately Day 19
Period 1: t1/2 of Rosuvastatin
Blood samples will be collected at multiple time points to determine the t1/2 of rosuvastatin.
Measured: Predose and at designated timepoints up to approximately 96 hours
Period 2: t1/2 of Rosuvastatin
Blood samples will be collected at multiple time points to determine the t1/2 of rosuvastatin.
Measured: Predose and at designated timepoints up to approximately Day 19
Period 1: CL/F of Rosuvastatin
Blood samples will be collected at multiple time points to determine the CL/F of rosuvastatin.
Measured: Predose and at designated timepoints up to approximately 96 hours
Period 2: CL/F of Rosuvastatin
Blood samples will be collected at multiple time points to determine the CL/F of rosuvastatin.
Measured: Predose and at designated timepoints up to approximately Day 19
Period 1: Vz/F of Rosuvastatin
Blood samples will be collected at multiple time points to determine the Vz/F of rosuvastatin.
Measured: Predose and at designated timepoints up to approximately 96 hours
Period 2: Vz/F of Rosuvastatin
Blood samples will be collected at multiple time points to determine the Vz/F of rosuvastatin.
Measured: Predose and at designated timepoints up to approximately Day 19
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported.
Measured: Up to approximately 2 months
Number of Participants Who Discontinue Study Drug Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 23 days
Period 2 Day 1: Plasma Concentration at 12 Hours (C12) of MK-6916
Blood samples will be collected at multiple time points to determine the C12 of MK-6916.
Measured: Day 1: predose and at designated timepoints up to approximately 12 hours post dose
Period 2 Day 1: C12 of MK-6916 Metabolite (M5)
Blood samples will be collected at multiple time points to determine the C12 of MK-6916 metabolite (M5).
Measured: Day 1: predose and at designated timepoints up to approximately 12 hours post dose
Period 2 Day 1: C12 of MK-6916 Metabolite (M9)
Blood samples will be collected at multiple time points to determine the C12 of MK-6916 metabolite (M9).
Measured: Day 1: predose and at designated timepoints up to approximately 12 hours post dose
Period 2 Day 14: C12 of MK-6916
Blood samples will be collected at multiple time points to determine the C12 of MK-6916.
Measured: Day 14: predose and at designated timepoints up to approximately 12 hours post dose
Period 2 Day 14: C12 of MK-6916 Metabolite (M5)
Blood samples will be collected at multiple time points to determine the C12 of MK-6916 metabolite (M5).
Measured: Day 14: predose and at designated timepoints up to approximately 12 hours post dose
Period 2 Day 14: C12 of MK-6916 Metabolite (M9)
Blood samples will be collected at multiple time points to determine the C12 of MK-6916 metabolite (M9).
Measured: Day 14: predose and at designated timepoints up to approximately 12 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion9 Feb 2027 (estimated)
- Study completion19 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862621
- Sponsor's protocol ID
- 6916-012
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-period Study to Evaluate the Effects of Multiple Oral Doses of MK-6916 on the Single-dose Pharmacokinetics of Midazolam and Rosuvastatin
- ClinicalTrials.gov ID
- NCT07862621
- Acronym / sponsor ID
- 6916-012
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 9 Feb 2027 (estimated)
- Study completion
- 19 Feb 2027 (estimated)
- First posted
- 7 Oct 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.
Researchers are looking for new treatments for pain. The goal of this trial is to learn if MK-6916 changes what happens to the midazolam and rosuvastatin in healthy participants' bodies. Researchers will compare the amount of midazolam and rosuvastatin in a participant's body over time when they are given with and without MK-6916.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midazolam + Rosuvastatin + MK-6916 | Experimental | Drug: Midazolam, Drug: Rosuvastatin, Drug: MK-6916In Period 1, participants will receive midazolam and rosuvastatin. In Period 2, participants will receive MK-6916, midazolam, and rosuvastatin. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is in good health
- Has a body mass index between 18 and 32 kg/m^2, inclusive
Key exclusion criteria (2 listed)
- Has history of cancer (malignancy)
- Has positive test(s) for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus
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 |
|---|---|---|
| MidazolamAdministered orally on Day 1 of Period 1 and on Days 2 and 14 of Period 2. | Drug | Midazolam + Rosuvastatin + MK-6916 |
| RosuvastatinAdministered orally on Day 1 of Period 1 and Day 14 of Period 2. | Drug | Midazolam + Rosuvastatin + MK-6916 |
| MK-6916Administered orally once every 12 hours on Days 1 through 18 in Period 2. | Drug | Midazolam + Rosuvastatin + MK-6916 |
Primary outcome
Period 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24 hours
Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam.
Period 2: AUC0-inf of Midazolam
Time frame: Predose and at designated timepoints up to approximately Day 15
Blood samples will be collected at multiple time points to determine the AUC0-inf of midazolam.
Period 1: AUC0-inf of Rosuvastatin
Time frame: Predose and at designated timepoints up to approximately 96 hours
Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin.
Period 2: AUC0-inf of Rosuvastatin
Time frame: Predose and at designated timepoints up to approximately Day 19
Blood samples will be collected at multiple time points to determine the AUC0-inf of rosuvastatin.
42 secondary outcomes
Period 1: AUC0-inf of Midazolam Metabolite (1-Hydroxymidazolam)
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: AUC0-inf of Midazolam Metabolite (1-Hydroxymidazolam)
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: AUC0-last of Midazolam
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: AUC0-last of Midazolam Metabolite (1-Hydroxymidazolam)
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: AUC0-last of Midazolam Metabolite (1-Hydroxymidazolam)
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Maximum Plasma Concentration (Cmax) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: Cmax of Midazolam
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Cmax of Midazolam Metabolite (1-Hydroxymidazolam)
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: Cmax of Midazolam Metabolite (1-Hydroxymidazolam)
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Time to Maximum Plasma Concentration (Tmax) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: Tmax of Midazolam
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Tmax of Midazolam Metabolite (1-Hydroxymidazolam)
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: Tmax of Midazolam Metabolite (1-Hydroxymidazolam)
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Apparent Terminal Half-life (t1/2) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: t1/2 of Midazolam
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: t1/2 of Midazolam Metabolite (1-Hydroxymidazolam)
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: t1/2 of Midazolam Metabolite (1-Hydroxymidazolam)
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Apparent Clearance (CL/F) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: CL/F of Midazolam
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Midazolam
Time frame: Predose and at designated timepoints up to approximately 24 hours
Period 2: Vz/F of Midazolam
Time frame: Predose and at designated timepoints up to approximately Day 15
Period 1: AUC0-last of Rosuvastatin
Time frame: Predose and at designated timepoints up to approximately 96 hours
Period 2: AUC0-last of Rosuvastatin
Time frame: Predose and at designated timepoints up to approximately Day 19
Period 1: Cmax of Rosuvastatin
Time frame: Predose and at designated timepoints up to approximately 96 hours
Period 2: Cmax of Rosuvastatin
Time frame: Predose and at designated timepoints up to approximately Day 19
Period 1: Tmax of Rosuvastatin
Time frame: Predose and at designated timepoints up to approximately 96 hours
Period 2: Tmax of Rosuvastatin
Time frame: Predose and at designated timepoints up to approximately Day 19
Period 1: t1/2 of Rosuvastatin
Time frame: Predose and at designated timepoints up to approximately 96 hours
Period 2: t1/2 of Rosuvastatin
Time frame: Predose and at designated timepoints up to approximately Day 19
Period 1: CL/F of Rosuvastatin
Time frame: Predose and at designated timepoints up to approximately 96 hours
Period 2: CL/F of Rosuvastatin
Time frame: Predose and at designated timepoints up to approximately Day 19
Period 1: Vz/F of Rosuvastatin
Time frame: Predose and at designated timepoints up to approximately 96 hours
Period 2: Vz/F of Rosuvastatin
Time frame: Predose and at designated timepoints up to approximately Day 19
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 2 months
Number of Participants Who Discontinue Study Drug Due to an AE
Time frame: Up to approximately 23 days
Period 2 Day 1: Plasma Concentration at 12 Hours (C12) of MK-6916
Time frame: Day 1: predose and at designated timepoints up to approximately 12 hours post dose
Period 2 Day 1: C12 of MK-6916 Metabolite (M5)
Time frame: Day 1: predose and at designated timepoints up to approximately 12 hours post dose
Period 2 Day 1: C12 of MK-6916 Metabolite (M9)
Time frame: Day 1: predose and at designated timepoints up to approximately 12 hours post dose
Period 2 Day 14: C12 of MK-6916
Time frame: Day 14: predose and at designated timepoints up to approximately 12 hours post dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midazolam, Rosuvastatin and MK-6916 in people with Healthy, run by Merck Sharp & Dohme LLC.
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 2 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: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Period 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Midazolam (time frame: Predose and at designated timepoints up to approximately 24 hours). 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 7 Oct 2026.