HealthyPhase 1NCT01069822
A Study in Healthy Volunteers to Assess Effect of AZD6765 on Midazolam Blood Levels
A Phase 1 study testing AZD6765 and midazolam in people with Healthy, run by AstraZeneca at 1 site in United States.
Trial summary
The main purpose of this study is to evaluate the effect repeated doses of AZD6765 (a drug being developed for the treatment of patients with severe major depressive disorder) has on the PK (pharmacokinetic) profile of Midazolam. (The PK profile is how the drug leaves your body and acts in the body.) 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?
- AZD6765 and midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to May 2010
- 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
- BMI between 19-30
Who cannot join
- Significant result for C-SSRS at screening or baseline
- Single arm preference for IV procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Open-label, Fixed Sequence Study to Determine the Effect of Multiple Intravenous Doses of AZD6765 on the Pharmacokinetics of Oral Midazolam (CYP3A4 Substrate) in Healthy Subjects
The main purpose of this study is to evaluate the effect repeated doses of AZD6765 (a drug being developed for the treatment of patients with severe major depressive disorder) has on the PK (pharmacokinetic) profile of Midazolam. (The PK profile is how the drug leaves your body and acts in the body.)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6765Drug
IV solution
midazolamDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | midazolam + AZD6765 IV solution Receives: Drug: AZD6765; Drug: midazolam |
| 2 | Active comparator | Not described Receives: Drug: midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations
Measured: on Day -1 and Day 6
Secondary outcomes (3)
Safety variables (adverse events, vital signs, physical and neurological examinations, clinical laboratory assessments, 12-lead ECG, C-SSRS, CADSS, and VAS scales)
Measured: will be collected from the time of informed consent (Visit 1) until completion of the follow-up visit.
Optional Genetic sampling
Measured: at admission Day -2
Exploratory - renal biomarkers in urine
Measured: At admission Day -2 until follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionMay 2010
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 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Willie Earley, MD, Study director, AstraZenecaBrendan Smyth, MD, Ph.D, Study director, AstraZenecaPhil Leese, MD, Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069822
- Sponsor's protocol ID
- D6702C00008
- Status last verified
- Oct 2014
- First submitted
- 15 Feb 2010
- Last updated
- 13 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label, Fixed Sequence Study to Determine the Effect of Multiple Intravenous Doses of AZD6765 on the Pharmacokinetics of Oral Midazolam (CYP3A4 Substrate) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01069822
- Acronym / sponsor ID
- D6702C00008
- Conditions
- Healthy
- Keywords
- Midazolam, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 17 Feb 2010 (estimated)
- 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 main purpose of this study is to evaluate the effect repeated doses of AZD6765 (a drug being developed for the treatment of patients with severe major depressive disorder) has on the PK (pharmacokinetic) profile of Midazolam. (The PK profile is how the drug leaves your body and acts in the body.)
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD6765, Drug: midazolammidazolam + AZD6765 IV solution |
| 2 | Active comparator | Drug: midazolam |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI between 19-30
Key exclusion criteria (2 listed)
- Significant result for C-SSRS at screening or baseline
- Single arm preference for IV procedures
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 |
|---|---|---|
| AZD6765IV solution | Drug | 1 |
| midazolam | Drug | 1, 2 |
Primary outcome
Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations
Time frame: on Day -1 and Day 6
3 secondary outcomes
Safety variables (adverse events, vital signs, physical and neurological examinations, clinical laboratory assessments, 12-lead ECG, C-SSRS, CADSS, and VAS scales)
Time frame: will be collected from the time of informed consent (Visit 1) until completion of the follow-up visit.
Optional Genetic sampling
Time frame: at admission Day -2
Exploratory - renal biomarkers in urine
Time frame: At admission Day -2 until follow up visit
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 13 Oct 2014.
- D6702C00008 Clinical Study Report SynopsisLink provided by the sponsor.
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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.
Willie Earley, MD study director
AstraZeneca
Brendan Smyth, MD, Ph.D study director
AstraZeneca
Phil Leese, MD principal investigator
Quintiles, 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 AZD6765 and midazolam in people with Healthy, run by AstraZeneca 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 1 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: finished, as of the sponsor's last update on 13 Oct 2014. 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?
Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations (time frame: on Day -1 and Day 6). 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 13 Oct 2014.