Healthy Young VolunteersPhase 1NCT01739647
A Single Dose Study to Assess the Safety, Effects, and Blood and Urine Drug Levels of AZD3293 in Healthy Subjects
A Phase 1 study testing AZD3293 in people with Healthy Young Volunteers and Healthy Elderly Volunteers, run by AstraZeneca at 1 site in United States.
Trial summary
This is a single dose study in healthy male and female (of non-child bearing potential) volunteers, to assess the safety, effects on the body, and blood and urine drug levels of AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Volunteers, Healthy Elderly Volunteers
- What is being tested?
- AZD3293
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to May 2013
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female (of non-childbearing potential) subjects
- Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Who cannot join
- History or presence of psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders
- History of neurological disease, including seizures, recent memory impairment, or clinically significant head injury
- History of use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs
- Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 Including an Open-Label Food Effect Group in Healthy Male and Non-Fertile Female Volunteers
This is a single dose study in healthy male and female (of non-child bearing potential) volunteers, to assess the safety, effects on the body, and blood and urine drug levels of AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease
Read the detailed description
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 Including an Open-Label Food Effect Group in Healthy Male and Non-Fertile Female Volunteers
- Being tested
- AZD3293, Placebo
- Keywords
- AZD3293, Healthy volunteers, Elderly volunteers, Phase 1, Single Ascending Dose Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3293Drug
Oral solution
PlaceboDrug
Oral solution
| Study group | Role | What they receive |
|---|---|---|
| AZD3293 | Experimental | Up to 11 sequential cohorts of healthy young and healthy elderly subjects are planned, with single ascending doses ranging from 1mg to a maximum of 1000mg Receives: Drug: AZD3293 |
| Placebo | Placebo comparator | Placebo given (2 subjects in each cohort) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event monitoring.
Measured: From baseline up to 10 days.
Assessment of vital signs and physical examination.
The vital signs of body temperature, blood pressure and pulse are going to be measured.
Measured: From baseline up to 10 days.
Clinical laboratory tests: hematology.
Measured: From baseline up to 10 days.
Clinical laboratory tests: urine analysis.
Measured: From baseline up to 10 days.
Evaluation of 12-lead digital electrocardiogram (ECG).
QT/QTc interval, rhythm, rate, morphology is going to be measured.
Measured: From baseline up to 10 days.
Assessment of telemetry.
As reported by investigator.
Measured: From baseline up to 10 days.
Columbia-Suicide Severity Rating Scale (C-SSRS)
Columbia-Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Measured: From baseline up to 10 days.
Secondary outcomes (6)
Pharmacokinetics (PK) in the terms of AUC, AUC(0-t), AUC(0-24).
Where (AUC(0-t)) is area under the plasma concentration-time curve from zero to the last measurable concentration and (AUC(0-24)) area under the plasma concentration-time curve from zero to 24 hours post-dose.
Measured: Up 4 days
Investigation on the effect of AZD3293 on biomarkers relevant for Pharmacodynamics in plasma.
Biomarker PD Aβ (1-40, 1-42) parameters are:
- Maximum observed plasma concentration (Cmax)
- Time to Cmax (tmax)
- Minimum observed plasma concentration (Cmin)
- Minimum observed plasma concentration below the individual healthy volunteer baseline (pre-dose biomarker concentration prior to dosing) (ΔCmin)
- Time to Cmin (tmin)
- Duration (T) of concentration below individual healthy volunteer baseline (BBL), if appropriate for the data (tBBL)
- Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC(0-t))
- Area under the plasma concentration-time curve from zero to 24 hours post dose (AUC(0-24))
- Area under the plasma biomarker concentration curve from time zero to 24 hour that is below individual healthy volunteer baseline (ΔAUC(0-24)).
Measured: Up to 4 days.
Investigation of the potential influence of food on Pharmacokinetics (PK) following a single dose of AZD3293.
Pharmacokinetics (PK) in the terms of plasma Cmax and AUC.
Measured: Up to 4 days.
Investigation of the relationship between Pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD3293.
The Pharmacokinetics (PK) variables may be plasma concentrations or summary measurements such as Cmax or AUC. The Pharmacodynamics (PD) variables may include biomarkers in plasma such as Aβ (1-40, 1-42) or exploratory PD biomarkers, or safety variables.
Measured: Up to 4 days.
Pharmacokinetics assessment in the terms of fu (%) (fraction of unbound AZD3293 and AZ13569724 in plasma).
Measured: Up to 4 days.
Pharmacokinetics in the terms of Cmax (Maximum observed plasma concentration) and tmax (Time to Cmax ).
Measured: Up to 4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young VolunteersStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert C Alexander, MD, Study director, AstraZenecaRonald Goldwater, MD, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739647
- Sponsor's protocol ID
- D5010C00001
- Status last verified
- Aug 2013
- First submitted
- 30 Nov 2012
- Last updated
- 27 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 Including an Open-Label Food Effect Group in Healthy Male and Non-Fertile Female Volunteers
- ClinicalTrials.gov ID
- NCT01739647
- Acronym / sponsor ID
- D5010C00001
- Keywords
- AZD3293, Healthy volunteers, Elderly volunteers, Phase 1, Single Ascending Dose Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 3 Dec 2012 (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.
This is a single dose study in healthy male and female (of non-child bearing potential) volunteers, to assess the safety, effects on the body, and blood and urine drug levels of AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease
Detailed description
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 Including an Open-Label Food Effect Group in Healthy Male and Non-Fertile Female Volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD3293 | Experimental | Drug: AZD3293Up to 11 sequential cohorts of healthy young and healthy elderly subjects are planned, with single ascending doses ranging from 1mg to a maximum of 1000mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo given (2 subjects in each cohort) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male and female (of non-childbearing potential) subjects
- Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Key exclusion criteria (4 listed)
- History or presence of psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders
- History of neurological disease, including seizures, recent memory impairment, or clinically significant head injury
- History of use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs
- Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products
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 |
|---|---|---|
| AZD3293Oral solution | Drug | AZD3293 |
| PlaceboOral solution | Drug | Placebo |
Primary outcome
Adverse event monitoring.
Time frame: From baseline up to 10 days.
Assessment of vital signs and physical examination.
Time frame: From baseline up to 10 days.
The vital signs of body temperature, blood pressure and pulse are going to be measured.
Clinical laboratory tests: hematology.
Time frame: From baseline up to 10 days.
Clinical laboratory tests: urine analysis.
Time frame: From baseline up to 10 days.
Evaluation of 12-lead digital electrocardiogram (ECG).
Time frame: From baseline up to 10 days.
QT/QTc interval, rhythm, rate, morphology is going to be measured.
Assessment of telemetry.
Time frame: From baseline up to 10 days.
As reported by investigator.
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: From baseline up to 10 days.
Columbia-Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
6 secondary outcomes
Pharmacokinetics (PK) in the terms of AUC, AUC(0-t), AUC(0-24).
Time frame: Up 4 days
Investigation on the effect of AZD3293 on biomarkers relevant for Pharmacodynamics in plasma.
Time frame: Up to 4 days.
Investigation of the potential influence of food on Pharmacokinetics (PK) following a single dose of AZD3293.
Time frame: Up to 4 days.
Investigation of the relationship between Pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD3293.
Time frame: Up to 4 days.
Pharmacokinetics assessment in the terms of fu (%) (fraction of unbound AZD3293 and AZ13569724 in plasma).
Time frame: Up to 4 days.
Pharmacokinetics in the terms of Cmax (Maximum observed plasma concentration) and tmax (Time to Cmax ).
Time frame: Up to 4 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 27 Aug 2013.
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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.
Robert C Alexander, MD study director
AstraZeneca
Ronald Goldwater, MD principal investigator
Parexel
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 in people with Healthy Young Volunteers and Healthy Elderly Volunteers, 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 2 inclusion and 4 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 27 Aug 2013. 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?
Adverse event monitoring. (time frame: From baseline up to 10 days.). The study lists 7 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 27 Aug 2013.