HealthyPhase 1JSMADNCT01100047
Japanese Single and Multiple Ascending Dose (JSMAD), Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of AZD5069
A Phase 1 study testing AZD5069 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound, AZD5069. It will also assess how the body handles the drug and how it responds to the drug following single and multiple doses up to 11 days. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD5069
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2010to Feb 2011
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Japanese subjects with suitable veins for cannulation or repeated venepuncture.
- Have a body mass index (BMI) between 17 and 27 kg/m2 and a body weight between 45 and 80 kg
- Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product.
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator
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, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 in Healthy Japanese Subjects After Single and Multiple Ascending Doses
This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound, AZD5069. It will also assess how the body handles the drug and how it responds to the drug following single and multiple doses up to 11 days.
- Conditions
- Healthy
- Being tested
- AZD5069, Placebo
- Keywords
- Phase I, Japanese healthy volunteer, AZD5069
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5069Drug
Oral suspension
PlaceboDrug
Oral suspension
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD5069 |
| 2 | 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, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry
Measured: From screening period to follow-up visit 42 days (Maximum)
Secondary outcomes (3)
Assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood
Measured: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
Measurement of the effect of AZD5069 on blood cells
Measured: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
Pharmacokinetic profile: concentration of AZD5069 in blood
Measured: Baselines at Visit 1 or pre-dose Day 1, assessments Visit 2, post-dose until 96hr post final dose. Follow up assessments at Visit 3. Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrike Lorch, Lorch, MD MFPM FRCA, Principal investigator, Richmond Pharmacology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100047
- Sponsor's protocol ID
- D3550C00005
- Other IDs
- 2009-018185-35, 2009
- Acronym
- JSMAD
- Status last verified
- Jun 2015
- First submitted
- 24 Mar 2010
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cullberg M, Arfvidsson C, Larsson B, Malmgren A, Mitchell P, Wahlby Hamren U, Wray H. Pharmacokinetics of the Oral Selective CXCR2 Antagonist AZD5069: A Summary of Eight Phase I Studies in Healthy Volunteers. Drugs R D. 2018 Jun;18(2):149-159. doi: 10.1007/s40268-018-0236-x.
PubMed 29856004
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. 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, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 in Healthy Japanese Subjects After Single and Multiple Ascending Doses
- ClinicalTrials.gov ID
- NCT01100047
- Acronym / sponsor ID
- JSMAD / D3550C00005
- Conditions
- Healthy
- Keywords
- Phase I, Japanese healthy volunteer, AZD5069
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 8 Apr 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 study in Japanese healthy volunteers to determine the safety and tolerability of the compound, AZD5069. It will also assess how the body handles the drug and how it responds to the drug following single and multiple doses up to 11 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD5069 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Japanese subjects with suitable veins for cannulation or repeated venepuncture.
- Have a body mass index (BMI) between 17 and 27 kg/m2 and a body weight between 45 and 80 kg
- Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product
Key exclusion criteria (4 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product.
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator
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 |
|---|---|---|
| AZD5069Oral suspension | Drug | 1 |
| PlaceboOral suspension | Drug | 2 |
Primary outcome
Adverse events, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry
Time frame: From screening period to follow-up visit 42 days (Maximum)
3 secondary outcomes
Assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood
Time frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
Measurement of the effect of AZD5069 on blood cells
Time frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
Pharmacokinetic profile: concentration of AZD5069 in blood
Time frame: Baselines at Visit 1 or pre-dose Day 1, assessments Visit 2, post-dose until 96hr post final dose. Follow up assessments at Visit 3. Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-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 25 Jun 2015.
- Derived from this study: PubMed 29856004Cullberg M, Arfvidsson C, Larsson B, Malmgren A, Mitchell P, Wahlby Hamren U, Wray H. Pharmacokinetics of the Oral Selective CXCR2 Antagonist AZD5069: A Summary of Eight Phase I Studies in Healthy Volunteers. Drugs R D. 2018 Jun;18(2):149-159. doi: 10.1007/s40268-018-0236-x.
- CSR SynopsisLink provided by the sponsor.
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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.
Ulrike Lorch, Lorch, MD MFPM FRCA principal investigator
Richmond Pharmacology Limited
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 AZD5069 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 3 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: finished, as of the sponsor's last update on 25 Jun 2015. 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, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry (time frame: From screening period to follow-up visit 42 days (Maximum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01100047, which also lists 1 linked publication.
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 25 Jun 2015.