HealthyPhase 1JSAD/JMADNCT00698282
Single and Multiple Ascending Doses of AZD1981 in Japan
A Phase 1 study testing AZD1981 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in healthy Japanese 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?
- AZD1981
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2008to Oct 2008
- 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
- Healthy Japanese and Caucasian males
Who cannot join
- Other clinically relevant disease or disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Placebo-Controlled, Double-Blind, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of AZD1981 in Healthy Male Japanese and Caucasian Subjects
The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in healthy Japanese subjects
- Conditions
- Healthy
- Being tested
- AZD1981, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1981Drug
Oral tablet, 250 mg single dose
AZD1981Drug
Suspension, 15, 75, 1000 and 2000 mg
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD1981 |
| 2 | Experimental | Not described Receives: Drug: AZD1981 |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: All the time
Plasma drug concentration
Measured: Every hour
Secondary outcomes (1)
Clinical chemistry
Measured: day 1 and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2008
- Study completionOct 2008
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elizabeth Hancox, Principal investigator, Europe Chiltern International Ltd, Berkshire, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698282
- Sponsor's protocol ID
- D9831C00005
- Acronym
- JSAD/JMAD
- Status last verified
- Nov 2010
- First submitted
- 16 Jun 2008
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-Controlled, Double-Blind, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of AZD1981 in Healthy Male Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT00698282
- Acronym / sponsor ID
- JSAD/JMAD / D9831C00005
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 17 Jun 2008 (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 study safety, tolerability and pharmacokinetics of AZD1981 in healthy Japanese subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1981 |
| 2 | Experimental | Drug: AZD1981 |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Japanese and Caucasian males
Key exclusion criteria (1 listed)
- Other clinically relevant disease or disorders
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 |
|---|---|---|
| AZD1981Oral tablet, 250 mg single dose | Drug | 1 |
| AZD1981Suspension, 15, 75, 1000 and 2000 mg | Drug | 2 |
| Placebo | Drug | 3 |
Primary outcome
Adverse events
Time frame: All the time
Plasma drug concentration
Time frame: Every hour
1 secondary outcome
Clinical chemistry
Time frame: day 1 and 9
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 1 Dec 2010.
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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.
Elizabeth Hancox principal investigator
Europe Chiltern International Ltd, Berkshire, UK
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 AZD1981 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
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 1 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 1 Dec 2010. 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 Kingdom. 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 events (time frame: All the time). The study lists 2 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 1 Dec 2010.