Cardiovascular DiseasePhase 1NCT04492709
A Study to Assess the Effect of Multiple Doses of AZD5718 on Pharmacokinetics of Oral Midazolam in Healthy Subjects
A Phase 1 study testing Midazolam and AZD5718 in people with Cardiovascular Disease, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
In clinical practice, AZD5718 will be co-administered with CYP3A substrates. Therefore, it is important to determine the impact of AZD5718 on the pharmacokinetics (PK) of CYP3A4 substrates. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Midazolam and AZD5718
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2020to 19 Oct 2020
- 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
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male and female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
- Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle stimulating hormone levels in the postmenopausal range.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation.
- Male subject must adhere to the contraception methods details.
- Have a body mass index between 18.5 and 30 kg/m2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- History or presence of acute pulmonary insufficiency, marked neuromuscular respiratory weakness, obsessional states, phobic states, sleep apnea syndrome, or unstable myasthenia gravis.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at screening and/or on admission to the Clinical Unit, as judged by the Investigator, including:
- Alanine aminotransferase > 1.5 x upper limit of normal (ULN);
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- Aspartate aminotransferase > 1.5 x ULN;
- Bilirubin (total) > 1.5 x ULN; and
- Gamma glutamyl transpeptidase > 1.5 x ULN.
- Any clinically significant abnormal findings in vital signs (blood pressure and pulse; supine) at screening and/or admission to the Clinical Unit, as judged by the Investigator.
- Any clinically significant abnormalities on 12-lead electrocardiogram at screening, as judged by the Investigator.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody.
- Known or suspected Gilbert syndrome.
- Known or suspected history of drug abuse in the last 2 years, as judged by the Investigator.
- Has received another new chemical or biological entity within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or 1 month after the last visit whichever is the longest.
- Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator. History of hypersensitivity to drugs with a similar chemical structure or class to AZD5718 or known hypersensitivity to benzodiazepines or to any formulation excipients.
- Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening.
- Positive screen for drugs of abuse or cotinine at screening or on admission to the study unit, or positive screen for alcohol on screening or on admission to the study unit.
- Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
- Use of any prescribed (other than hormone-replacement therapy for females) or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.
- Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by the Investigator. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the investigational site.
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the Investigator. Excessive intake of alcohol defined as the regular consumption of more than 24 g of alcohol per day for men or 12 g of alcohol per day for women.
- Involvement of any AstraZeneca, Parexel, or study site employee or their close relatives.
- Subjects who have previously received AZD5718.
- Subjects with history of lactose intolerance.
- Judgment by the Investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
- Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
- Subjects who cannot communicate reliably with the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Fixed Sequence, Open-Label Study to Assess the Effect of Multiple Doses of AZD5718 on the Pharmacokinetics of Oral Midazolam (a CYP450 3A Probe) in Healthy Subjects
In clinical practice, AZD5718 will be co-administered with CYP3A substrates. Therefore, it is important to determine the impact of AZD5718 on the pharmacokinetics (PK) of CYP3A4 substrates. The primary objective of this study is to evaluate the effect of AZD5718 on the PK of midazolam, a known sensitive CYP3A4 substrate.
Read the detailed description
This is a Phase 1, fixed sequence, open-label study in healthy subjects, performed at a single study center. This study will consist of 3 treatment periods to assess the PK of midazolam when administered alone and in combination with multiple doses of AZD5718.
The study will comprise:
- A screening period of maximum 28 days;
- Three treatment periods during which subjects will be resident from the day before first dosing (Day -1) until at least 24 hours after last dosing (Day 7); discharged on the morning of Day 8, and;
- A final Follow-up Visit within 5 to 7 days after the last administration of investigational medicinal product (IMP).
- Conditions
- Cardiovascular Disease
- Being tested
- Midazolam, AZD5718
- Keywords
- AZD5718, CYP3A4 substrate, Drug-drug Interaction, Fixed sequence, Midazolam, Open-label, Pharmacokinetics
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
The subjects will receive single doses of midazolam solution 2 mg/mL orally on Day 1 alone in Treatment Period 1 and on Day 7 co-administered with oral AZD5718 tablet in Treatment Period 3.
AZD5718Drug
The subjects will receive oral AZD5718 tablet once daily starting on Day 2 to Day 6 in Treatment Period 2 and on Day 7 co-administered with midazolam in Treatment Period 3.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The subjects will receive oral midazolam solution of 2 mg as a single dose on 2 occasions, 6 days apart (Days 1 and 7). The first dose will be prior to dosing with oral AZD5718 tablet and the second dose after five administrations of AZD5718 under fasted conditions. Receives: Drug: Midazolam; Drug: AZD5718 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma peak concentration (Cmax) of midazolam
Comparison of Cmax calculated when midazolam alone and calculated when midazolam was taken together with AZD5718
Measured: Day 1-Day 2 and Day 7-Day 8: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours (h) post-dose
Area under plasma concentration-time curve from time zero to infinity (AUCinf) of midazolam
Comparison of AUCinf calculated when midazolam alone and calculated when midazolam was taken together with AZD5718
Measured: Day 1-Day 2 and Day 7-Day 8: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 h post-dose
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of midazolam
Comparison of AUClast calculated when midazolam alone and calculated when midazolam was taken together with AZD5718
Measured: Day 1-Day 2 and Day 7-Day 8: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 h post-dose
Time to reach maximum observed plasma concentration (tmax) of midazolam
Comparison of tmax calculated when midazolam alone and calculated when midazolam was taken together with AZD5718
Measured: Day 1-Day 2 and Day 7-Day 8: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 h post-dose
Half-life (t1/2) of midazolam
Comparison of t1/2 calculated when midazolam alone and calculated when midazolam was taken together with AZD5718
Measured: Day 1-Day 2 and Day 7-Day 8: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 h post-dose
Plasma concentrations of AZD5718
AZD5718 Plasma concentrations will be evaluated at trough and also at the expected time of tmax
Measured: Day 2-Day 7: at trough and Day 7: 4 h post-dose
Secondary outcomes (9)
Number of subjects with adverse events (AEs) and serious AEs
The number and percentage of subjects with AEs and the number of events including for both AZD5718 alone and in combination with midazolam
Measured: AE: From Day 1 to post-treatment follow-up visit (Day 13); SAE: From screening to post-treatment follow-up visit (Day 13)
Number of subjects with abnormal 12-lead electrocardiogram (ECG)
12-lead resting ECG safety assessments if there are any abnormal findings or if the Investigator considers it is required for any other safety reason including for both AZD5718 alone and in combination with midazolam
Measured: At screening and post-treatment follow-up visit (Day 13)
Number of subjects with abnormal physical examination
Any new or aggravated clinically relevant abnormal medical physical examination finding compared to the baseline assessment including for both AZD5718 alone and in combination with midazolam
Measured: At screening, Day -1, Day 1, Day 4, Day 7, Day 8, and post-treatment follow-up visit (Day 13)
Number of subjects with abnormal blood pressure (BP)
Observed values and change from baseline value in systolic and diastolic BP including for both AZD5718 alone and in combination with midazolam
Measured: For approximately 6 weeks (from screening to post-treatment follow-up)
Number of subjects with abnormal pulse rate
Observed values and change from baseline value in pulse rate including for both AZD5718 alone and in combination with midazolam
Measured: For approximately 6 weeks (from screening to post-treatment follow-up)
Number of subjects with abnormal oxygen saturation levels
Observed values and change from baseline value in oxygen saturation including for both AZD5718 alone and in combination with midazolam
Measured: On Day 1 and Day 7: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8 and 12 h post-dose
Number of subjects with abnormal hematology parameters
Observed values and change from baseline value in hematology including for both AZD5718 alone and in combination with midazolam
Measured: At screening, Day -1, Day 1 (pre-dose), Day 2 and Day 4 (pre-dose), Day 7 (pre-dose), Day 8, and post-treatment follow-up visit (Day 13)
Number of subjects with abnormal clinical chemistry parameters
Observed values and change from baseline value in clinical chemistry including for both AZD5718 alone and in combination with midazolam
Measured: At screening, Day -1, Day 1 (pre-dose), Day 2 and Day 4 (pre-dose), Day 7 (pre-dose), Day 8, and post-treatment follow-up visit (Day 13)
Number of subjects with abnormal urine analysis parameters
Observed values and change from baseline value in urine analysis including for both AZD5718 alone and in combination with midazolam
Measured: At screening, Day -1, Day 1 (pre-dose), Day 2 and Day 4 (pre-dose), Day 7 (pre-dose), Day 8, and post-treatment follow-up visit (Day 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start30 Jul 2020
- Primary completion19 Oct 2020
- Study completion19 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Fixed sequence
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Dr. Pablo Forte Soto, MD, MSc, PhD, Principal investigator, Parexel Early Phase Clinical Unit London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492709
- Sponsor's protocol ID
- D7550C00011
- Status last verified
- Oct 2020
- First submitted
- 28 Jul 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Fixed Sequence, Open-Label Study to Assess the Effect of Multiple Doses of AZD5718 on the Pharmacokinetics of Oral Midazolam (a CYP450 3A Probe) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04492709
- Acronym / sponsor ID
- D7550C00011
- Conditions
- Cardiovascular Disease
- Keywords
- AZD5718, CYP3A4 substrate, Drug-drug Interaction, Fixed sequence, Midazolam, Open-label, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 19 Oct 2020 (actual)
- First posted
- 30 Jul 2020 (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.
In clinical practice, AZD5718 will be co-administered with CYP3A substrates. Therefore, it is important to determine the impact of AZD5718 on the pharmacokinetics (PK) of CYP3A4 substrates. The primary objective of this study is to evaluate the effect of AZD5718 on the PK of midazolam, a known sensitive CYP3A4 substrate.
Detailed description
This is a Phase 1, fixed sequence, open-label study in healthy subjects, performed at a single study center. This study will consist of 3 treatment periods to assess the PK of midazolam when administered alone and in combination with multiple doses of AZD5718.
The study will comprise:
- A screening period of maximum 28 days;
- Three treatment periods during which subjects will be resident from the day before first dosing (Day -1) until at least 24 hours after last dosing (Day 7); discharged on the morning of Day 8, and;
- A final Follow-up Visit within 5 to 7 days after the last administration of investigational medicinal product (IMP).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fixed sequence
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Midazolam, Drug: AZD5718The subjects will receive oral midazolam solution of 2 mg as a single dose on 2 occasions, 6 days apart (Days 1 and 7). The first dose will be prior to dosing with oral AZD5718 tablet and the second dose after five administrations of AZD5718 under fasted conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male and female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:
- Male subject must adhere to the contraception methods details.
- Have a body mass index between 18.5 and 30 kg/m2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive.
Key exclusion criteria (29 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- History or presence of acute pulmonary insufficiency, marked neuromuscular respiratory weakness, obsessional states, phobic states, sleep apnea syndrome, or unstable myasthenia gravis.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at screening and/or on admission to the Clinical Unit, as judged by the Investigator, including:
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 |
|---|---|---|
| MidazolamThe subjects will receive single doses of midazolam solution 2 mg/mL orally on Day 1 alone in Treatment Period 1 and on Day 7 co-administered with oral AZD5718 tablet in Treatment Period 3. | Drug | Treatment |
| AZD5718The subjects will receive oral AZD5718 tablet once daily starting on Day 2 to Day 6 in Treatment Period 2 and on Day 7 co-administered with midazolam in Treatment Period 3. | Drug | Treatment |
Primary outcome
Maximum observed plasma peak concentration (Cmax) of midazolam
Time frame: Day 1-Day 2 and Day 7-Day 8: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours (h) post-dose
Comparison of Cmax calculated when midazolam alone and calculated when midazolam was taken together with AZD5718
Area under plasma concentration-time curve from time zero to infinity (AUCinf) of midazolam
Time frame: Day 1-Day 2 and Day 7-Day 8: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 h post-dose
Comparison of AUCinf calculated when midazolam alone and calculated when midazolam was taken together with AZD5718
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of midazolam
Time frame: Day 1-Day 2 and Day 7-Day 8: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 h post-dose
Comparison of AUClast calculated when midazolam alone and calculated when midazolam was taken together with AZD5718
Time to reach maximum observed plasma concentration (tmax) of midazolam
Time frame: Day 1-Day 2 and Day 7-Day 8: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 h post-dose
Comparison of tmax calculated when midazolam alone and calculated when midazolam was taken together with AZD5718
Half-life (t1/2) of midazolam
Time frame: Day 1-Day 2 and Day 7-Day 8: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 h post-dose
Comparison of t1/2 calculated when midazolam alone and calculated when midazolam was taken together with AZD5718
Plasma concentrations of AZD5718
Time frame: Day 2-Day 7: at trough and Day 7: 4 h post-dose
AZD5718 Plasma concentrations will be evaluated at trough and also at the expected time of tmax
9 secondary outcomes
Number of subjects with adverse events (AEs) and serious AEs
Time frame: AE: From Day 1 to post-treatment follow-up visit (Day 13); SAE: From screening to post-treatment follow-up visit (Day 13)
Number of subjects with abnormal 12-lead electrocardiogram (ECG)
Time frame: At screening and post-treatment follow-up visit (Day 13)
Number of subjects with abnormal physical examination
Time frame: At screening, Day -1, Day 1, Day 4, Day 7, Day 8, and post-treatment follow-up visit (Day 13)
Number of subjects with abnormal blood pressure (BP)
Time frame: For approximately 6 weeks (from screening to post-treatment follow-up)
Number of subjects with abnormal pulse rate
Time frame: For approximately 6 weeks (from screening to post-treatment follow-up)
Number of subjects with abnormal oxygen saturation levels
Time frame: On Day 1 and Day 7: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8 and 12 h post-dose
Number of subjects with abnormal hematology parameters
Time frame: At screening, Day -1, Day 1 (pre-dose), Day 2 and Day 4 (pre-dose), Day 7 (pre-dose), Day 8, and post-treatment follow-up visit (Day 13)
Number of subjects with abnormal clinical chemistry parameters
Time frame: At screening, Day -1, Day 1 (pre-dose), Day 2 and Day 4 (pre-dose), Day 7 (pre-dose), Day 8, and post-treatment follow-up visit (Day 13)
Number of subjects with abnormal urine analysis parameters
Time frame: At screening, Day -1, Day 1 (pre-dose), Day 2 and Day 4 (pre-dose), Day 7 (pre-dose), Day 8, and post-treatment follow-up visit (Day 13)
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 3 Nov 2020.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
Dr. Pablo Forte Soto, MD, MSc, PhD principal investigator
Parexel Early Phase Clinical Unit London
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 Midazolam and AZD5718 in people with Cardiovascular Disease, run by AstraZeneca at 1 site in United Kingdom.
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 7 inclusion and 29 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 3 Nov 2020. 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 Kingdom. 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?
Maximum observed plasma peak concentration (Cmax) of midazolam (time frame: Day 1-Day 2 and Day 7-Day 8: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours (h) post-dose). 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 3 Nov 2020.