HealthyPhase 1NCT01233830
Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 Multiple Doses in Healthy Japanese Volunteers
A Phase 1 study testing AZD2423 in people with Healthy, run by AstraZeneca at 1 site in Japan.
Trial summary
The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD2423 in young and elderly healthy Japanese volunteers. 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?
- AZD2423
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2010to Mar 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
- Healthy Japanese male volunteers aged ≥20 to ≤45 years and healthy Japanese male and female volunteers aged ≥65 to ≤80 years with suitable veins for cannulation or repeated venipuncture
- Have a body mass index (BMI) between ≥17 and ≤27 kg/m2, as calculated by the investigator(s), and weigh at least 45 kg and no more than 100 kg
- Clinically normal physical findings including supine blood pressure, 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(s), 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
- Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the investigator(s), within 3 months of the first administration of investigational product or known malignancy within the past 5 years (with the exception of successfully treated basal cell carcinoma)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single Centre, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 Solution After Administration of Multiple Ascending Doses for 12 Days in Young and Elderly Healthy Japanese Volunteers
The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD2423 in young and elderly healthy Japanese volunteers.
- Conditions
- Healthy
- Being tested
- AZD2423, Placebo
- Keywords
- safety, tolerability, pharmacokinetics, AZD2423, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2423Drug
oral solution
PlaceboDrug
oral solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD2423 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse events
Measured: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Vital signs
Changes from baseline in systolic blood pressure, pulse rate and body temperature
Measured: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Electrocardiograms
Measured: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Laboratory Variables (hematology, urinalysis and clinical chemistry)
Measured: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Secondary outcomes (1)
Plasma concentration over time
Measured: Pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionMar 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bror Jonzon, MD, PhD, Study director, AstraZeneca R&D SödertäljeAkimasa Watanabe, Principal investigator, Kyushu Clinical Pharmacology Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233830
- Sponsor's protocol ID
- D2600C00004
- Status last verified
- Apr 2011
- First submitted
- 19 Oct 2010
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Centre, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 Solution After Administration of Multiple Ascending Doses for 12 Days in Young and Elderly Healthy Japanese Volunteers
- ClinicalTrials.gov ID
- NCT01233830
- Acronym / sponsor ID
- D2600C00004
- Conditions
- Healthy
- Keywords
- safety, tolerability, pharmacokinetics, AZD2423, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 3 Nov 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 purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD2423 in young and elderly healthy Japanese 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 |
|---|---|---|
| 1 | Experimental | Drug: AZD2423 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy Japanese male volunteers aged ≥20 to ≤45 years and healthy Japanese male and female volunteers aged ≥65 to ≤80 years with suitable veins for cannulation or repeated venipuncture
- Have a body mass index (BMI) between ≥17 and ≤27 kg/m2, as calculated by the investigator(s), and weigh at least 45 kg and no more than 100 kg
- Clinically normal physical findings including supine blood pressure, pulse rate, ECG, and laboratory assessments in relation to age, as judged by the investigator(s)
Key exclusion criteria (3 listed)
- History of any clinically significant disease or disorder which, in the opinion of the investigator(s), 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
- Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the investigator(s), within 3 months of the first administration of investigational product or known malignancy within the past 5 years (with the exception of successfully treated basal cell carcinoma)
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 |
|---|---|---|
| AZD2423oral solution | Drug | 1 |
| Placebooral solution | Drug | 2 |
Primary outcome
Number of participants with Adverse events
Time frame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Vital signs
Time frame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Changes from baseline in systolic blood pressure, pulse rate and body temperature
Electrocardiograms
Time frame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Laboratory Variables (hematology, urinalysis and clinical chemistry)
Time frame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
1 secondary outcome
Plasma concentration over time
Time frame: Pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours after the first dose
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 12 Apr 2011.
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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.
Bror Jonzon, MD, PhD study director
AstraZeneca R&D Södertälje
Akimasa Watanabe principal investigator
Kyushu Clinical Pharmacology Research Clinic
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 AZD2423 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 4 inclusion and 3 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 12 Apr 2011. 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?
Number of participants with Adverse events (time frame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)). The study lists 4 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 12 Apr 2011.