Alzheimer's DiseasePhase 1AZD3293TQTNCT02040987
AZD3293 Thorough QT Study in Healthy Male Volunteers
A Phase 1 study testing AZD3293 and Moxifloxacin in people with Alzheimer's Disease, run by AstraZeneca at 1 site in United States.
Trial summary
A thorough QT study of AZD3293 Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- AZD3293 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to May 2014
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed, written and dated informed consent prior to any study-specific procedures
- Healthy male subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements
- Healthy male subjects aged 18 to 55 years
- Body weight ≥ 50 to ≤ 100 kg and body mass index (BMI) ≥19 to ≤30
- Clinically normal findings on physical examination in relation to age, as judged by the investigator.
Who cannot join
- History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject'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 of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder
- History of neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury
- History of psychotic disorder among first degree relatives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared to Placebo, Using Open-Label AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Subjects
A thorough QT study of AZD3293
Read the detailed description
A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared to Placebo, Using Open-Label AVELOX (moxifloxacin) as a Positive Control, in Healthy Male Subjects
- Conditions
- Alzheimer's Disease
- Being tested
- AZD3293, Placebo, Moxifloxacin
- Keywords
- Thorough QT study
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3293Drug
Also called beta secretase inhibitor
AZD3293 oral solution - one single dose (low dose).
AZD3293Drug
AZD3293 oral solution - one single dose (high dose).
PlaceboDrug
Placebo oral solution - one single dose
MoxifloxacinDrug
Moxifloxacin tablet - one single dose
| Study group | Role | What they receive |
|---|---|---|
| AZD3293 dose A | Experimental | AZD3293 therapeutic dose oral solution (low dose) Receives: Drug: AZD3293 |
| AZD3293 dose B | Experimental | AZD3293 supratherapeutic dose oral solution (high dose) Receives: Drug: AZD3293 |
| Placebo | Placebo comparator | Placebo oral solution Receives: Drug: Placebo |
| Moxifloxacin | Active comparator | Moxifloxacin tablet Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of a single dose of AZD3293 low dose and high dose on the change in time-matched QTcF intervals compared with placebo.
The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula
Measured: Up to 69 days
Secondary outcomes (4)
The effect of a single oral dose of moxifloxacin on the changes in time-matched QTcF intervals compared with placebo.
The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula.
Measured: Up to 69 days
The safety and tolerability of AZD3293 in healthy male subjects by assessing a panel of adverse events measures
Physical examination, electrocardiogram, pulse and blood pressure, weight and laboratory variables
Measured: Up to 69 days
Plasma concentrations, AUC, Cmax and tmax of single dose AZD3293 and moxifloxacin in healthy male subjects
AUC(0-t): Area under the concentration versus time curve from time 0 to the time of the last quantifiable concentration to be calculated by a combination of linear and logarithmic trapezoidal methods (linear up-log down) Cmax: Maximum observed plasma concentration obtained directly from the concentration vs. time data tmax: Time to reach Cmax following dose, obtained directly from the concentration vs. time data
Measured: Up to 69 days
The effect of AZD3293 on additional electrocardiogram (ECG) variables (heart rate, RR, PR, QRS, QT and QTcB)
RR: The time between corresponding points on 2 consecutive R waves on ECG. PR: ECG interval measured from the onset of the P wave to the onset of the QRS complex. QRS: ECG interval measured from the onset of the QRS complex to the J point. QT: ECG interval measured from the onset of the QRS complex to the offset of the T wave. QTcB: The heart rate corrected QT calculated using Bazett's formula.
Measured: Up to 69 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Ronald Goldwater, MD, Principal investigator, Parexel ECPU Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040987
- Sponsor's protocol ID
- D5010C00008
- Acronym
- AZD3293TQT
- Status last verified
- Jul 2014
- First submitted
- 17 Jan 2014
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared to Placebo, Using Open-Label AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02040987
- Acronym / sponsor ID
- AZD3293TQT / D5010C00008
- Conditions
- Alzheimer's Disease
- Keywords
- Thorough QT study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Jan 2014 (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.
A thorough QT study of AZD3293
Detailed description
A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared to Placebo, Using Open-Label AVELOX (moxifloxacin) as a Positive Control, in Healthy Male Subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AZD3293 dose A | Experimental | Drug: AZD3293AZD3293 therapeutic dose oral solution (low dose) |
| AZD3293 dose B | Experimental | Drug: AZD3293AZD3293 supratherapeutic dose oral solution (high dose) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral solution |
| Moxifloxacin | Active comparator | Drug: MoxifloxacinMoxifloxacin tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provision of signed, written and dated informed consent prior to any study-specific procedures
- Healthy male subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements
- Healthy male subjects aged 18 to 55 years
- Body weight ≥ 50 to ≤ 100 kg and body mass index (BMI) ≥19 to ≤30
- Clinically normal findings on physical examination in relation to age, as judged by the investigator.
Key exclusion criteria (5 listed)
- History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject'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 of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder
- History of neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury
- History of psychotic disorder among first degree relatives
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 |
|---|---|---|
| AZD3293Also: beta secretase inhibitorAZD3293 oral solution - one single dose (low dose). | Drug | AZD3293 dose A |
| AZD3293AZD3293 oral solution - one single dose (high dose). | Drug | AZD3293 dose B |
| PlaceboPlacebo oral solution - one single dose | Drug | Placebo |
| MoxifloxacinMoxifloxacin tablet - one single dose | Drug | Moxifloxacin |
Primary outcome
The effect of a single dose of AZD3293 low dose and high dose on the change in time-matched QTcF intervals compared with placebo.
Time frame: Up to 69 days
The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula
4 secondary outcomes
The effect of a single oral dose of moxifloxacin on the changes in time-matched QTcF intervals compared with placebo.
Time frame: Up to 69 days
The safety and tolerability of AZD3293 in healthy male subjects by assessing a panel of adverse events measures
Time frame: Up to 69 days
Plasma concentrations, AUC, Cmax and tmax of single dose AZD3293 and moxifloxacin in healthy male subjects
Time frame: Up to 69 days
The effect of AZD3293 on additional electrocardiogram (ECG) variables (heart rate, RR, PR, QRS, QT and QTcB)
Time frame: Up to 69 days
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 Jul 2014.
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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.
Ronald Goldwater, MD principal investigator
Parexel ECPU Baltimore
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 AZD3293 and Moxifloxacin in people with Alzheimer's Disease, 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 5 inclusion and 5 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 Jul 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. Some participants in this study may receive a placebo. 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?
The effect of a single dose of AZD3293 low dose and high dose on the change in time-matched QTcF intervals compared with placebo. (time frame: Up to 69 days). 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 Jul 2014.