HealthyPhase 1NCT01335451
Assess the Safety, Tolerability and Pharmacokinetics of AZD5213 After Single and Multiple Ascending Oral Doses in Healthy Young and Elderly Japanese Subjects
A Phase 1 study testing AZD5213 in people with Healthy, run by AstraZeneca at 1 site in Japan.
Trial summary
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD5213 in healthy young and elderly Japanese subjects Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD5213
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2011to Oct 2011
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Japanese healthy male subjects aged 20 to 45 years (young) and male and female subjects aged 65 to 80 years (elderly)
- Male subjects should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after the last dose of investigational product
- Have a body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 45 kg and no more than 100 kg
- Clinically normal physical findings, supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator(s)
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the investigator, 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, and personality disorder including borderline according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders
- History of psychotic disorder among first degree relatives.
- History of use of antipsychotic, antidepressant or anxiolytic drugs, prescribed as well as non-prescribed use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5213 After Oral Administration of Single and Multiple Ascending Doses in Healthy Young and Elderly J
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD5213 in healthy young and elderly Japanese subjects
- Conditions
- Healthy
- Being tested
- AZD5213, Placebo
- Keywords
- AZD5213, safety, pharmacokinetics, single dose, repeated dose, young, elderly, Japanese, healthy subject
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5213Drug
Four increasing doses for young and two increasing doses for elderly subjects. Subject will receive single dose of AZD5213 oral solution (Day 1) and then start the once daily repeated doses from Day 3 to 12 for 10 days
PlaceboDrug
Placebo solution, single dose (Day 1) and repeated dose from Day 3 to 12 for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Each cohort will have 6 subjects that will receive AZD5213 Receives: Drug: AZD5213 |
| Placebo | Placebo comparator | Each cohort will have 2 subjects that will receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of AZD5213 by assessment of adverse event, vital signs, laboratory parameters and electrocardiograms (ECGs).
Measured: Range of Days 1-12
Secondary outcomes (7)
To assess the PK of AZD5213 after a single and multiple doses by assessment of Cmax.
Measured: Range of Days 1-12
To assess the PK of AZD5213 after a single and multiple doses by assessment of fe.
Measured: Range of Days 1-12
To assess the PK of AZD5213 after a single and multiple doses by assessment of CLR.
Measured: Range of Days 1-12
To assess the PK of AZD5213 after a single and multiple doses by assessment of CL/F.
Measured: Range of Days 1-12
To assess the PK of AZD5213 after a single and multiple doses by assessment of t1/2.
Measured: Range of Days 1-12
To assess the PK of AZD5213 after a single and multiple doses by assessment of tmax.
Measured: Range of Days 1-12
To assess the PK of AZD5213 after a single and multiple doses by assessment of AUC.
Measured: Range of Days 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionOct 2011
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Märta Segerdahl, MD, PhD, Study director, AstraZeneca R&D, SödertäljeAkimasa Watanabe, MD, Principal investigator, Kyushu Clinical Pharmacology Research Clinic, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335451
- Sponsor's protocol ID
- D3030C00004
- Status last verified
- Jan 2015
- First submitted
- 13 Apr 2011
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5213 After Oral Administration of Single and Multiple Ascending Doses in Healthy Young and Elderly J
- ClinicalTrials.gov ID
- NCT01335451
- Acronym / sponsor ID
- D3030C00004
- Conditions
- Healthy
- Keywords
- AZD5213, safety, pharmacokinetics, single dose, repeated dose, young, elderly, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 14 Apr 2011 (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 purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD5213 in healthy young and elderly Japanese subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: AZD5213Each cohort will have 6 subjects that will receive AZD5213 |
| Placebo | Placebo comparator | Drug: PlaceboEach cohort will have 2 subjects that will receive placebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Japanese healthy male subjects aged 20 to 45 years (young) and male and female subjects aged 65 to 80 years (elderly)
- Male subjects should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after the last dose of investigational product
- Have a body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 45 kg and no more than 100 kg
- Clinically normal physical findings, supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator(s)
Key exclusion criteria (5 listed)
- History of any clinically significant disease or disorder which, in the opinion of the investigator, 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, and personality disorder including borderline according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders
- History of psychotic disorder among first degree relatives.
- History of use of antipsychotic, antidepressant or anxiolytic drugs, prescribed as well as non-prescribed use.
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 |
|---|---|---|
| AZD5213Four increasing doses for young and two increasing doses for elderly subjects. Subject will receive single dose of AZD5213 oral solution (Day 1) and then start the once daily repeated doses from Day 3 to 12 for 10 days | Drug | Active |
| PlaceboPlacebo solution, single dose (Day 1) and repeated dose from Day 3 to 12 for 10 days | Drug | Placebo |
Primary outcome
To assess the safety and tolerability of AZD5213 by assessment of adverse event, vital signs, laboratory parameters and electrocardiograms (ECGs).
Time frame: Range of Days 1-12
7 secondary outcomes
To assess the PK of AZD5213 after a single and multiple doses by assessment of Cmax.
Time frame: Range of Days 1-12
To assess the PK of AZD5213 after a single and multiple doses by assessment of fe.
Time frame: Range of Days 1-12
To assess the PK of AZD5213 after a single and multiple doses by assessment of CLR.
Time frame: Range of Days 1-12
To assess the PK of AZD5213 after a single and multiple doses by assessment of CL/F.
Time frame: Range of Days 1-12
To assess the PK of AZD5213 after a single and multiple doses by assessment of t1/2.
Time frame: Range of Days 1-12
To assess the PK of AZD5213 after a single and multiple doses by assessment of tmax.
Time frame: Range of Days 1-12
To assess the PK of AZD5213 after a single and multiple doses by assessment of AUC.
Time frame: Range of Days 1-12
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 2015.
- D3030C00004\_Clinical\_Study\_Report\_Synopsis.pdfLink 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.
Märta Segerdahl, MD, PhD study director
AstraZeneca R&D, Södertälje
Akimasa Watanabe, MD principal investigator
Kyushu Clinical Pharmacology Research Clinic, Japan
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 AZD5213 in people with Healthy, run by AstraZeneca at 1 site in Japan.
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 28 Jan 2015. 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 Japan. 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?
To assess the safety and tolerability of AZD5213 by assessment of adverse event, vital signs, laboratory parameters and electrocardiograms (ECGs). (time frame: Range of Days 1-12). 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 2015.