Healthy VolunteersPhase 1NCT00931541
AZD6088 Single Ascending Dose Study
A Phase 1 study testing AZD6088 in people with Healthy Volunteers, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The aims of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD6088 following single ascending dose administration in healthy male and non-fertile females. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AZD6088
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2009to Aug 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian male and non-fertile female healthy volunteers aged ≥18 to ≤55 years with suitable veins for cannulation or repeated venipuncture.
- Clinically normal physical findings including supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator.
- Normal and suitable EEG, as judged by a neurologist
Who cannot join
- History of any clinically significant disease or disorder which for instance includes CNS disorder or CV disorder.
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator.
- Any clinically important abnormalities in the ECG.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD6088 After Single Ascending Doses in Healthy Male and Non-Fertile Female Volunteers
The aims of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD6088 following single ascending dose administration in healthy male and non-fertile females.
- Conditions
- Healthy Volunteers
- Being tested
- AZD6088, Placebo
- Keywords
- Safety, Tolerability, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6088Drug
Oral solution. Each subject will receive a single-dose of AZD6088.
PlaceboDrug
Oral solution. Each subject will receive a single-dose of placebo.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | AZD6088 oral solution Receives: Drug: AZD6088 |
| B | Experimental | Placebo oral solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp)
Measured: Sampling occasions during all visits.
Secondary outcomes (2)
Pharmacokinetics
Measured: Intense PK-sampling during 3 pre-defined study days for PK profiling.
Pharmacodynamics
Measured: Sampling occasions during 3 pre-defined study days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Biljana Lilja, Study director, AstraZeneca R&D, Södertälje, SwedenMarianne Kasti, Principal investigator, Quintiles GDRU, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931541
- Sponsor's protocol ID
- D0840C00007
- Other IDs
- EudraCT N0. 2008-007936-17
- Status last verified
- Sep 2009
- First submitted
- 30 Jun 2009
- Last updated
- 10 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD6088 After Single Ascending Doses in Healthy Male and Non-Fertile Female Volunteers
- ClinicalTrials.gov ID
- NCT00931541
- Acronym / sponsor ID
- D0840C00007
- Conditions
- Healthy Volunteers
- Keywords
- Safety, Tolerability, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Jul 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 aims of the study are to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD6088 following single ascending dose administration in healthy male and non-fertile females.
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 |
|---|---|---|
| A | Experimental | Drug: AZD6088AZD6088 oral solution |
| B | Experimental | Drug: PlaceboPlacebo oral solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Caucasian male and non-fertile female healthy volunteers aged ≥18 to ≤55 years with suitable veins for cannulation or repeated venipuncture.
- Clinically normal physical findings including supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator.
- Normal and suitable EEG, as judged by a neurologist
Key exclusion criteria (3 listed)
- History of any clinically significant disease or disorder which for instance includes CNS disorder or CV disorder.
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator.
- Any clinically important abnormalities in the ECG.
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 |
|---|---|---|
| AZD6088Oral solution. Each subject will receive a single-dose of AZD6088. | Drug | A |
| PlaceboOral solution. Each subject will receive a single-dose of placebo. | Drug | B |
Primary outcome
Safety variables (vital signs, ECG, EEG, safety laboratory values, body temp)
Time frame: Sampling occasions during all visits.
2 secondary outcomes
Pharmacokinetics
Time frame: Intense PK-sampling during 3 pre-defined study days for PK profiling.
Pharmacodynamics
Time frame: Sampling occasions during 3 pre-defined study 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 Sep 2009.
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Healthy
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.
Biljana Lilja study director
AstraZeneca R&D, Södertälje, Sweden
Marianne Kasti principal investigator
Quintiles GDRU, London, 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 AZD6088 in people with Healthy Volunteers, 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 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 10 Sep 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 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. 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 variables (vital signs, ECG, EEG, safety laboratory values, body temp) (time frame: Sampling occasions during all visits.). 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 Sep 2009.