Healthy VolunteerPhase 1NCT00767052
Investigate the Safety Tolerability and Pharmacokinetics of Multiple Doses of AZD1236
A Phase 1 study testing AZD1236 in people with Healthy Volunteer, run by AstraZeneca at 1 site in Japan.
Trial summary
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of multiple ascending oral doses of AZD1236 given to healthy young subjects for 13 days and to evaluate the single-dose relative bioavailability of the oral suspension and oral tablet formulations. 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 Volunteer
- What is being tested?
- AZD1236
- 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
- Sep 2008to Dec 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
- Provision of signed informed consent prior to any study specific procedures
- Body Mass Index (BMI) between 19-27 kg/m2
Who cannot join
- Receipt of another investigational drug in the 4 months before dosing in this study
- Acute illness which requires medical intervention within 2 weeks of Visit 2.
- Abnormal resting BP and pulse rate (after resting for 10 minutes). Supine blood pressure > 140 mmHg systolic or >90 mmHg diastolic, pulse<= 50 or => 90 beats per minute
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Single Centre Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral Multiple Ascending Daily Doses of AZD1236 Tablet by a Single-Blind, Placebo-Controlled, and Single Dose Relative Bioavailability of the Oral Suspension and Oral Tablet Formulations by an Open Cross-Over in Healthy Japanese Men
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of multiple ascending oral doses of AZD1236 given to healthy young subjects for 13 days and to evaluate the single-dose relative bioavailability of the oral suspension and oral tablet formulations.
- Conditions
- Healthy Volunteer
- Being tested
- AZD1236, Placebo
- Keywords
- Healthy Volunteer, Safety, Tolerability, Pharmacokinetics, AZD1236
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1236Drug
75mg once daily or 75mg twice daily will be administered in multiple dose part.
PlaceboDrug
Placebo tablet matching to the active in multiple dose part.
AZD1236Drug
75mg single dose will be administered in relative bioavailability part.
AZD1236Drug
75mg oral suspension single dose will be administered in relative bioavailability part.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | AZD1236 tablet Receives: Drug: AZD1236 |
| Placebo | Placebo comparator | Placebo tablet Receives: Drug: Placebo |
| Relative bioavailability | Other | AZD1236 Oral suspension Receives: Drug: AZD1236 |
| Relative bioavailability tablet | Other | AZD1236 tablet Receives: Drug: AZD1236 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of AZD1236 by assessment of blood pressure, pulse rate, body temperature, laboratory variables, ECG and adverse events
Measured: Assessments taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow up visit. Volunteers will be monitored throughout the study for adverse events.
Secondary outcomes (1)
Pharmacokinetic profile: concentration of AZD1236 in blood
Measured: Samples taken during Visit 2 in multiple dosing part at 41 points and Visit 2/3 in relative bioavailability part at 32 points.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shunji Matsuki, MD PhD, Principal investigator, Kyushu Clinical Pharmacology Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767052
- Sponsor's protocol ID
- D4260C00006
- Status last verified
- Jun 2009
- First submitted
- 3 Oct 2008
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Single Centre Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral Multiple Ascending Daily Doses of AZD1236 Tablet by a Single-Blind, Placebo-Controlled, and Single Dose Relative Bioavailability of the Oral Suspension and Oral Tablet Formulations by an Open Cross-Over in Healthy Japanese Men
- ClinicalTrials.gov ID
- NCT00767052
- Acronym / sponsor ID
- D4260C00006
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, Safety, Tolerability, Pharmacokinetics, AZD1236
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Oct 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 investigate the safety, tolerability and pharmacokinetics of multiple ascending oral doses of AZD1236 given to healthy young subjects for 13 days and to evaluate the single-dose relative bioavailability of the oral suspension and oral tablet formulations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: AZD1236AZD1236 tablet |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet |
| Relative bioavailability | Other | Drug: AZD1236AZD1236 Oral suspension |
| Relative bioavailability tablet | Other | Drug: AZD1236AZD1236 tablet |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Provision of signed informed consent prior to any study specific procedures
- Body Mass Index (BMI) between 19-27 kg/m2
Key exclusion criteria (3 listed)
- Receipt of another investigational drug in the 4 months before dosing in this study
- Acute illness which requires medical intervention within 2 weeks of Visit 2.
- Abnormal resting BP and pulse rate (after resting for 10 minutes). Supine blood pressure > 140 mmHg systolic or >90 mmHg diastolic, pulse<= 50 or => 90 beats per minute
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 |
|---|---|---|
| AZD123675mg once daily or 75mg twice daily will be administered in multiple dose part. | Drug | Active |
| PlaceboPlacebo tablet matching to the active in multiple dose part. | Drug | Placebo |
| AZD123675mg single dose will be administered in relative bioavailability part. | Drug | Relative bioavailability |
| AZD123675mg oral suspension single dose will be administered in relative bioavailability part. | Drug | Relative bioavailability tablet |
Primary outcome
Safety and tolerability of AZD1236 by assessment of blood pressure, pulse rate, body temperature, laboratory variables, ECG and adverse events
Time frame: Assessments taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow up visit. Volunteers will be monitored throughout the study for adverse events.
1 secondary outcome
Pharmacokinetic profile: concentration of AZD1236 in blood
Time frame: Samples taken during Visit 2 in multiple dosing part at 41 points and Visit 2/3 in relative bioavailability part at 32 points.
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 30 Jun 2009.
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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.
Shunji Matsuki, MD PhD 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 AZD1236 in people with Healthy Volunteer, 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 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 30 Jun 2009. 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?
Safety and tolerability of AZD1236 by assessment of blood pressure, pulse rate, body temperature, laboratory variables, ECG and adverse events (time frame: Assessments taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow up visit. Volunteers will be monitored throughout the study for adverse events.). 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 30 Jun 2009; AzTrials last refreshed its copy on 8 Nov 2026.