Healthy ParticipantsPhase 1NCT06648824
Study of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants
A Phase 1 study testing Mitapivat and Midazolam in people with Healthy Participants, run by Agios Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the effect of mitapivat on the single oral dose pharmacokinetics (PK) of midazolam in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Mitapivat and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2024to 3 Dec 2024
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females must not be pregnant or lactating.
- Females of childbearing potential must agree to use contraception.
- Body mass index between 18.0 and 32.0 kilogram per meter square (kg/m^2), inclusive.
- In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG) and vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in, and from the physical examination at check-in, as assessed by the investigator or designee.
- Able to comprehend and willing to sign the informed consent form (ICF) and abide by the study restrictions.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, ophthalmological (acute angle closure glaucoma), or psychiatric disorder, as determined by the investigator or designee.
- History of significant hypersensitivity, intolerance, or allergy to any relevant drug compound, food, or other substance (ie, allergy to study intervention or excipients [microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, mannitol, magnesium stearate, and the Opadry Blue II film-coat [hypromellose, titanium dioxide, lactose monohydrate, triacetin, and FD\&C Blue #2]]).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (e.g., cholecystectomy). Uncomplicated appendectomy and hernia repair are allowed.
- Significant acute, new-onset illness (e.g., flu, gastroenteritis) within 2 weeks prior to dosing.
- Confirmed systolic blood pressure >150 or <90 millimeters of mercury (mmHg), diastolic blood pressure >100 or <50 mmHg, or pulse rate >100 or <40 beats per minute (bpm). If any parameter falls outside of the specified range at screening or check-in, 2 repeat measurements will be performed and the participant will be excluded only if the mean of the parameter based on the 3 replicates falls outside of the specified range.
- Clinically significant cardiac history or presence of ECG findings, including any of the following:
Show all 32Show fewer
- Heart rate <40 bpm or >100 bpm
- Risk factors for torsades de pointes (e.g., heart failure, cardiomyopathy, or family history of long QT syndrome)
- Sick sinus syndrome, second- or third-degree atrioventricular block myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, or conduction abnormalities
- QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 millisecond (msec) (healthy male participants) or >470 msec (healthy female participants); if QTcF is >450 msec (males) or >470 msec (females), 2 repeat measurements will be performed and the participant will be excluded only if the mean QTcF based on the 3 replicate ECGs is >450 msec (males) or >470 msec (females).
- QRS duration >110 msec, confirmed by manual overread; if value is >110 msec, 2 repeat measurements will be performed and the participant will be excluded only if the mean QRS duration based on the 3 replicate ECGs is >110 msec.
- PR interval <120 or >220 msec, confirmed by manual overread; if value is <120 or >220 msec, 2 repeat measurements will be performed and the participant will be excluded only if the mean PR interval based on the 3 replicate ECGs is <120 or >220 msec.
- Repeated syncope or vasovagal episodes.
- Hypertension, angina, bradycardia (if assessed as clinically significant by the investigator) or severe peripheral arterial circulatory disorders
- History of autonomic dysfunction.
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- Administration of any vaccine within 30 days prior to dosing.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Use or intend to use any prescription medications/products, other than non-hormonal contraceptives, within 14 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Use or intend to use any slow-release medications/products considered to still be active within 14 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Use or intend to use any nonprescription medications/products including vitamins, minerals, high-dose biotin supplements and other supplements, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Participation in a clinical study involving administration of an investigational medicinal product (new chemical entity) in the past 30 days or 5 half-lives of that drug (if known) prior to dosing, whichever is longer.
- Has previously completed or withdrawn from this study or any other study investigating mitapivat and has previously received mitapivat.
- Alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals 12-ounce (oz) (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
- Positive urine drug screen at screening; positive alcohol test result or positive urine drug screen at check-in.
- History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
- Use of tobacco- or nicotine-containing products within 3 months prior to check-in, or positive cotinine at screening or check-in. Ingestion of poppy seed-, Seville orange-, or grapefruit-containing foods or beverages within 7 days prior to check-in and not willing to refrain from consumption of these foods or beverages throughout the study until end of study.
- Consumption of caffeine- or xanthine-containing products within 48 hours prior to check-in and not willing to refrain from consumption of these products while at the study site.
- Consumption of vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussel sprouts, and mustard greens), or charbroiled meat within 7 days prior to dosing and not willing to refrain from consumption of these foods until end of study.
- Receipt of blood products within 2 months prior to check-in.
- Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
- Poor peripheral venous access.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Inc.
Dallas, Texas, 75247
About this study
Official title: A Phase 1, Open-label, One-Sequence Crossover Study to Assess the Effect of Mitapivat on the Pharmacokinetics of the CYP3A Substrate (Midazolam) in Healthy Participants
The primary purpose of this study is to assess the effect of mitapivat on the single oral dose pharmacokinetics (PK) of midazolam in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- Mitapivat, Midazolam
- Keywords
- AG-348, Mitapivat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitapivatDrug
Also called AG-348, PYRUKYND®, AG-348 sulfate hydrate, Mitapivat sulfate
Oral tablets
MidazolamDrug
Oral syrup
| Study group | Role | What they receive |
|---|---|---|
| Mitapivat and Midazolam | Experimental | Participants will receive single oral dose of 2 milligram (mg) midazolam on Day 1 followed by 100 mg mitapivat, orally, twice daily (BID) from Day 3 to 13. On Day 14, participants will receive single oral dose of 2 mg midazolam and 100 mg mitapivat orally, BID. Midazolam will be co-administered with morning mitapivat dose. Receives: Drug: Mitapivat; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve Extrapolated From Time Zero to Infinity (AUC0-infinity) of Midazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-t) of Midazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Maximum Observed Plasma Concentration (Cmax) of Midazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Secondary outcomes (22)
Area Under the Plasma Concentration-Time Curve From Time Zero to 12 Hours Post-dose (AUC0-12) of Mitapivat
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Maximum Observed Plasma Concentration (Cmax) of Mitapivat
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Area Under the Plasma Concentration-Time Curve Over a Dosing Interval (Tau) at Steady State (AUC0-tau,ss) of Mitapivat
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Mitapivat
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Time to Last Measurable Concentration (tlast) of Mitapivat
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Time to Reach Maximum Concentration (tmax) of Mitapivat
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) of 1'-hydroxymidazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-t) of 1'-hydroxymidazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Maximum Observed Plasma Concentration (Cmax) of 1'-hydroxymidazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Metabolite-to-Parent Ratio of Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) for Midazolam and 1'-hydroxymidazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Metabolite-to-Parent Ratios of Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-t) for Midazolam and 1'-hydroxymidazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Metabolite-to-Parent Ratio of Maximum Observed Plasma Concentration (Cmax) for Midazolam and 1'-hydroxymidazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Percentage of Area Under the Concentration-Time Curve Due to Extrapolation From the Last Quantifiable Concentration to Infinity (AUC%extrap) of Midazolam and 1'-hydroxymidazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Time to Last Measurable Concentration (tlast) of Midazolam and 1'-hydroxymidazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Time to Reach Maximum Concentration (tmax) of Midazolam and 1'-hydroxymidazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Terminal Elimination Half-Life (t1/2) of Midazolam and 1'-hydroxymidazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Apparent Total Body Clearance (CL/F) of Midazolam and 1'-hydroxymidazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Midazolam and 1'-hydroxymidazolam
Measured: Pre-dose and at multiple timepoints post-dose up to Day 14
Number of Participants With Adverse Events (AEs), AEs by Severity, and Relatedness to Study Treatment
Measured: Up to Day 24
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Assessments
Measured: Baseline up to Day 24
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters
Measured: Baseline up to Day 14
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Parameters
Measured: Baseline up to Day 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start17 Oct 2024
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Agios Pharmaceuticals, Inc.The 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single sequence crossover design
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agios Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Affairs, Study chair, Agios Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648824
- Sponsor's protocol ID
- AG348-C-027
- Status last verified
- Jan 2025
- First submitted
- 17 Oct 2024
- Last updated
- 28 Jan 2025
- 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, One-Sequence Crossover Study to Assess the Effect of Mitapivat on the Pharmacokinetics of the CYP3A Substrate (Midazolam) in Healthy Participants
- ClinicalTrials.gov ID
- NCT06648824
- Acronym / sponsor ID
- AG348-C-027
- Conditions
- Healthy Participants
- Keywords
- AG-348, Mitapivat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 18 Oct 2024 (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 primary purpose of this study is to assess the effect of mitapivat on the single oral dose pharmacokinetics (PK) of midazolam in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single sequence crossover design
| Arm | Type | Receives |
|---|---|---|
| Mitapivat and Midazolam | Experimental | Drug: Mitapivat, Drug: MidazolamParticipants will receive single oral dose of 2 milligram (mg) midazolam on Day 1 followed by 100 mg mitapivat, orally, twice daily (BID) from Day 3 to 13. On Day 14, participants will receive single oral dose of 2 mg midazolam and 100 mg mitapivat orally, BID. Midazolam will be co-administered with morning mitapivat dose. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females must not be pregnant or lactating.
- Females of childbearing potential must agree to use contraception.
- Body mass index between 18.0 and 32.0 kilogram per meter square (kg/m^2), inclusive.
- In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG) and vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in, and from the physical examination at check-in, as assessed by the investigator or designee.
- Able to comprehend and willing to sign the informed consent form (ICF) and abide by the study restrictions.
Key exclusion criteria (32 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, ophthalmological (acute angle closure glaucoma), or psychiatric disorder, as determined by the investigator or designee.
- History of significant hypersensitivity, intolerance, or allergy to any relevant drug compound, food, or other substance (ie, allergy to study intervention or excipients [microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, mannitol, magnesium stearate, and the Opadry Blue II film-coat [hypromellose, titanium dioxide, lactose monohydrate, triacetin, and FD\&C Blue #2]]).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (e.g., cholecystectomy). Uncomplicated appendectomy and hernia repair are allowed.
- Significant acute, new-onset illness (e.g., flu, gastroenteritis) within 2 weeks prior to dosing.
- Confirmed systolic blood pressure >150 or <90 millimeters of mercury (mmHg), diastolic blood pressure >100 or <50 mmHg, or pulse rate >100 or <40 beats per minute (bpm). If any parameter falls outside of the specified range at screening or check-in, 2 repeat measurements will be performed and the participant will be excluded only if the mean of the parameter based on the 3 replicates falls outside of the specified range.
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 |
|---|---|---|
| MitapivatAlso: AG-348, PYRUKYND®, AG-348 sulfate hydrate, Mitapivat sulfateOral tablets | Drug | Mitapivat and Midazolam |
| MidazolamOral syrup | Drug | Mitapivat and Midazolam |
Primary outcome
Area Under the Plasma Concentration-Time Curve Extrapolated From Time Zero to Infinity (AUC0-infinity) of Midazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-t) of Midazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Maximum Observed Plasma Concentration (Cmax) of Midazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
22 secondary outcomes
Area Under the Plasma Concentration-Time Curve From Time Zero to 12 Hours Post-dose (AUC0-12) of Mitapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Maximum Observed Plasma Concentration (Cmax) of Mitapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Area Under the Plasma Concentration-Time Curve Over a Dosing Interval (Tau) at Steady State (AUC0-tau,ss) of Mitapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Mitapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Time to Last Measurable Concentration (tlast) of Mitapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Time to Reach Maximum Concentration (tmax) of Mitapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) of 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-t) of 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Maximum Observed Plasma Concentration (Cmax) of 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Metabolite-to-Parent Ratio of Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) for Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Metabolite-to-Parent Ratios of Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-t) for Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Metabolite-to-Parent Ratio of Maximum Observed Plasma Concentration (Cmax) for Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Percentage of Area Under the Concentration-Time Curve Due to Extrapolation From the Last Quantifiable Concentration to Infinity (AUC%extrap) of Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Time to Last Measurable Concentration (tlast) of Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Time to Reach Maximum Concentration (tmax) of Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Terminal Elimination Half-Life (t1/2) of Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Apparent Total Body Clearance (CL/F) of Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Number of Participants With Adverse Events (AEs), AEs by Severity, and Relatedness to Study Treatment
Time frame: Up to Day 24
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Assessments
Time frame: Baseline up to Day 24
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters
Time frame: Baseline up to Day 14
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Parameters
Time frame: Baseline up to Day 24
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 28 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Medical Affairs study chair
Agios Pharmaceuticals, Inc.
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 Mitapivat and Midazolam in people with Healthy Participants, run by Agios Pharmaceuticals, Inc. 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 5 inclusion and 32 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 28 Jan 2025. 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?
Area Under the Plasma Concentration-Time Curve Extrapolated From Time Zero to Infinity (AUC0-infinity) of Midazolam (time frame: Pre-dose and at multiple timepoints post-dose up to Day 14). The study lists 3 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 28 Jan 2025.