HealthyPhase 1JMADNCT00945425
AZD7325 Japan Multiple Ascending Dose (MAD) Study
A Phase 1 study testing AZD7325 in people with Healthy, run by AstraZeneca.
Trial summary
The purpose of this study is to evaluate the safety and tolerability after repeated ascending doses of AZD7325 in Japanese healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD7325
- 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
- No sites listed yet
- Study dates
- Jul 2009to Nov 2009
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese subjects
Who cannot join
- Significant illness, as judged by the investigator, within 2 weeks of Day 1
- Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit
- Blood loss in excess of 200 mL within 30 days of Day 1, in excess of 400 mL within 90 days of Day 1, or in excess of 1200 mL within 1 year of Day 1
- Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor
About this study
Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male Japanese Subjects
The purpose of this study is to evaluate the safety and tolerability after repeated ascending doses of AZD7325 in Japanese healthy male subjects.
- Conditions
- Healthy
- Being tested
- AZD7325, Placebo
- Keywords
- Phase I, Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7325Drug
oral capsule, once or twice daily, 7 days
PlaceboDrug
oral capsule, once or twice daily, 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low dose or placebo, twice daily Receives: Drug: AZD7325; Drug: Placebo |
| 2 | Experimental | Low dose or placebo, once daily Receives: Drug: AZD7325; Drug: Placebo |
| 3 | Experimental | Middle dose or placebo, twice daily Receives: Drug: AZD7325; Drug: Placebo |
| 4 | Experimental | High dose or placebo, once daily Receives: Drug: AZD7325; 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 multiple ascending oral doses of AZD7325 compared to placebo in healthy male Japanese subjects by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEG.
Measured: Observations/Assessments are made at each visit (Screening visit, Treatment visit (Day 1-Day 9) and Follow-up visit).
Secondary outcomes (2)
To evaluate and characterize the pharmacokinetics of AZD7325 when given orally in multiple ascending doses by assessment of drug concentration in plasma and urine.
Measured: Blood and urine samples will be taken before and after study drug administration (up to 48 hours post dose).
To evaluate the effects on VAS, Ataxia assessments and CogState Battery (cognition).
Measured: Observations/Assessments are made during the treatment visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJul 2009
- Study completionNov 2009 (estimated)
Why it stopped: Decided to stop development of this compound globally
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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yuji Kumagai, MD, PhD, Principal investigator, Kitasato University East Hospital, Kanagawa, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945425
- Sponsor's protocol ID
- D1140C00015
- Acronym
- JMAD
- Status last verified
- Feb 2011
- First submitted
- 23 Jul 2009
- Last updated
- 16 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male Japanese Subjects
- ClinicalTrials.gov ID
- NCT00945425
- Acronym / sponsor ID
- JMAD / D1140C00015
- Conditions
- Healthy
- Keywords
- Phase I, Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decided to stop development of this compound globally
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Study completion
- Nov 2009 (estimated)
- First posted
- 24 Jul 2009 (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 evaluate the safety and tolerability after repeated ascending doses of AZD7325 in Japanese healthy male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD7325, Drug: PlaceboLow dose or placebo, twice daily |
| 2 | Experimental | Drug: AZD7325, Drug: PlaceboLow dose or placebo, once daily |
| 3 | Experimental | Drug: AZD7325, Drug: PlaceboMiddle dose or placebo, twice daily |
| 4 | Experimental | Drug: AZD7325, Drug: PlaceboHigh dose or placebo, once daily |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Japanese subjects
Key exclusion criteria (4 listed)
- Significant illness, as judged by the investigator, within 2 weeks of Day 1
- Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit
- Blood loss in excess of 200 mL within 30 days of Day 1, in excess of 400 mL within 90 days of Day 1, or in excess of 1200 mL within 1 year of Day 1
- Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor
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 |
|---|---|---|
| AZD7325oral capsule, once or twice daily, 7 days | Drug | 1, 2, 3, 4 |
| Placebooral capsule, once or twice daily, 7 days | Drug | 1, 2, 3, 4 |
Primary outcome
To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo in healthy male Japanese subjects by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEG.
Time frame: Observations/Assessments are made at each visit (Screening visit, Treatment visit (Day 1-Day 9) and Follow-up visit).
2 secondary outcomes
To evaluate and characterize the pharmacokinetics of AZD7325 when given orally in multiple ascending doses by assessment of drug concentration in plasma and urine.
Time frame: Blood and urine samples will be taken before and after study drug administration (up to 48 hours post dose).
To evaluate the effects on VAS, Ataxia assessments and CogState Battery (cognition).
Time frame: Observations/Assessments are made during the treatment visit.
Results and safety
The study was stopped early (reason given: Decided to stop development of this compound globally). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 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.
Yuji Kumagai, MD, PhD principal investigator
Kitasato University East Hospital, Kanagawa, Japan
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD7325 in people with Healthy, run by AstraZeneca.
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 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: stopped early, as of the sponsor's last update on 16 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Decided to stop development of this compound globally). Results are not available in the source record.
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 multiple ascending oral doses of AZD7325 compared to placebo in healthy male Japanese subjects by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEG. (time frame: Observations/Assessments are made at each visit (Screening visit, Treatment visit (Day 1-Day 9) and Follow-up visit).). 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 16 Feb 2011.