HealthyPhase 1NCT01021189
Study to Assess Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of AZD1446 to Japanese Subject
A Phase 1 study testing AZD1446 in people with Healthy, run by AstraZeneca at 1 site in Japan.
Trial summary
The primary aim of this study is to assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 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?
- AZD1446
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2009to Jun 2010
- 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
- Healthy Japanese subjects, aged ≥20 to ≤50 years for male young subjects, ≥65 to ≤80 years for male or post-menopausal female elderly subjects.
- BMI between 18 and 27 kg/m2 and weigh at least 50 kg and no more than 90 kg (for the elderly female, weigh at least 45 kg and no more than 90 kg).
Who cannot join
- History of Quincke oedema or angiooedema, or history of repeated episodes of urticaria.
- History or present symptoms or signs of asthma, airway hyperreactivity or obstructive lung disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Healthy Young and Elderly Japanese Volunteers After Oral Single and Multiple Ascending Doses
The primary aim of this study is to assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects.
- Conditions
- Healthy
- Being tested
- AZD1446, Placebo
- Keywords
- safety, tolerability, AZD1446, AD, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1446Drug
Oral solution Dose single and followed by 7-day multiple dosing.Specific doses depend on panel.
PlaceboDrug
Oral solution Dose single and followed by 7-day multiple dosing.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD1446 Receives: Drug: AZD1446 |
| 2 | Placebo comparator | 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 AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects by adverse events, vital signs, laboratory variables and ECG.
Measured: During the whole study period, ca. 50 days.
Secondary outcomes (1)
To determine pharmacokinetics(PK) of AZD1446 following single and multiple dosing of AZD1446 in healthy young and elderly Japanese subjects.
Measured: PK sampling taken at defined timepoints during residential period, 12 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2010
- Study completionJun 2010
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Björn Paulsson, MD, PhD, Study director, AstraZeneca R&D SödertäljeShunji Matsuki, MD, PhD, Principal investigator, Kyusyu Clinical Phramacology Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021189
- Sponsor's protocol ID
- D1950C00003
- Status last verified
- Jun 2010
- First submitted
- 23 Nov 2009
- Last updated
- 10 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Healthy Young and Elderly Japanese Volunteers After Oral Single and Multiple Ascending Doses
- ClinicalTrials.gov ID
- NCT01021189
- Acronym / sponsor ID
- D1950C00003
- Conditions
- Healthy
- Keywords
- safety, tolerability, AZD1446, AD, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 26 Nov 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 primary aim of this study is to assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1446AZD1446 |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Japanese subjects, aged ≥20 to ≤50 years for male young subjects, ≥65 to ≤80 years for male or post-menopausal female elderly subjects.
- BMI between 18 and 27 kg/m2 and weigh at least 50 kg and no more than 90 kg (for the elderly female, weigh at least 45 kg and no more than 90 kg).
Key exclusion criteria (2 listed)
- History of Quincke oedema or angiooedema, or history of repeated episodes of urticaria.
- History or present symptoms or signs of asthma, airway hyperreactivity or obstructive lung disease.
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 |
|---|---|---|
| AZD1446Oral solution Dose single and followed by 7-day multiple dosing.Specific doses depend on panel. | Drug | 1 |
| PlaceboOral solution Dose single and followed by 7-day multiple dosing. | Drug | 2 |
Primary outcome
To assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects by adverse events, vital signs, laboratory variables and ECG.
Time frame: During the whole study period, ca. 50 days.
1 secondary outcome
To determine pharmacokinetics(PK) of AZD1446 following single and multiple dosing of AZD1446 in healthy young and elderly Japanese subjects.
Time frame: PK sampling taken at defined timepoints during residential period, 12 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 10 Jun 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.
Björn Paulsson, MD, PhD study director
AstraZeneca R&D Södertälje
Shunji Matsuki, MD, PhD principal investigator
Kyusyu Clinical Phramacology 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 AZD1446 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 2 inclusion and 2 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 10 Jun 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 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 AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects by adverse events, vital signs, laboratory variables and ECG. (time frame: During the whole study period, ca. 50 days.). 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 10 Jun 2010.