HealthyPhase 1JMADNCT01116011
Multiple Ascending Dose Study for AZD 7268 in Japanese Healthy Male Volunteers
A Phase 1 study testing AZD7268 in people with Healthy, run by AstraZeneca at 1 site in Japan.
Trial summary
This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered AZD7268 after multiple ascending doses. 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?
- AZD7268
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2010to Jul 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of Informed Consent
- Healthy male subjects, with suitable veins for cannulation or repeated venipuncture
Who cannot join
- Inability to understand or cooperate with given information
- Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, Hepatitis C and syphilis test
- History of seizure (including infant febrile seizures) or family history of seizure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 When Given in Multiple Ascending Oral Doses in Japanese Healthy Male Subjects
This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered AZD7268 after multiple ascending doses.
- Conditions
- Healthy
- Being tested
- AZD7268, Placebo
- Keywords
- Phase I, Japanese Healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7268Drug
Capsule, Oral, BID
PlaceboDrug
Capsule, Oral, BID
| Study group | Role | What they receive |
|---|---|---|
| AZD7268 | Experimental | Not described Receives: Drug: AZD7268 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the safety and tolerability of AZD7268 by Adverse Events.
Measured: From first dosing throughout the treatment period and including the follow-up period
Secondary outcomes (2)
Characterize the PK parameters(Cmax, AUC,t1/2) of AZD7268 by assessment of drug concentrations in plasma
Measured: Blood samples will be taken from pre-dose until 48 hours post last dose
Characterize the PK parameters (CLr, Ae) of AZD7268 by assessment of drug concentrations in urine
Measured: Urine samples will be taken from post first dose until 48 hours post last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2010
- Study completionJul 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tomoe Fujita, Principal investigator, Kitasato University East Hospital, Kanagawa, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116011
- Sponsor's protocol ID
- D1151C00004
- Acronym
- JMAD
- Status last verified
- Nov 2010
- First submitted
- 13 Apr 2010
- Last updated
- 15 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 When Given in Multiple Ascending Oral Doses in Japanese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01116011
- Acronym / sponsor ID
- JMAD / D1151C00004
- Conditions
- Healthy
- Keywords
- Phase I, Japanese Healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 4 May 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.
This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered AZD7268 after multiple ascending doses.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD7268 | Experimental | Drug: AZD7268 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Provision of Informed Consent
- Healthy male subjects, with suitable veins for cannulation or repeated venipuncture
Key exclusion criteria (3 listed)
- Inability to understand or cooperate with given information
- Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, Hepatitis C and syphilis test
- History of seizure (including infant febrile seizures) or family history of seizure
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 |
|---|---|---|
| AZD7268Capsule, Oral, BID | Drug | AZD7268 |
| PlaceboCapsule, Oral, BID | Drug | Placebo |
Primary outcome
Investigate the safety and tolerability of AZD7268 by Adverse Events.
Time frame: From first dosing throughout the treatment period and including the follow-up period
2 secondary outcomes
Characterize the PK parameters(Cmax, AUC,t1/2) of AZD7268 by assessment of drug concentrations in plasma
Time frame: Blood samples will be taken from pre-dose until 48 hours post last dose
Characterize the PK parameters (CLr, Ae) of AZD7268 by assessment of drug concentrations in urine
Time frame: Urine samples will be taken from post first dose until 48 hours post last 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 15 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.
Tomoe Fujita principal investigator
Kitasato University East Hospital, Kanagawa, Japan
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 AZD7268 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 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 15 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 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?
Investigate the safety and tolerability of AZD7268 by Adverse Events. (time frame: From first dosing throughout the treatment period and including the follow-up period). 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 15 Dec 2010.