PharmacokineticsPhase 1NCT00844103
Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of AZD8566.
A Phase 1 study testing AZD8566 in people with Pharmacokinetics, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine how well tolerated and safe AZD8566 is when given over 10 days, at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- AZD8566
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Apr 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of written informed consent.
- Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
- Females who are permanently or surgically sterile or postmenopausal and males.
Who cannot join
- Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug
- History of any convulsions or seizures
- History of infection or at risk of infection due to recent surgery or trauma
- History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomised, Double Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of AZD8566 in Healthy Volunteers
The purpose of this study is to determine how well tolerated and safe AZD8566 is when given over 10 days, at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.
- Conditions
- Pharmacokinetics
- Being tested
- AZD8566, Placebo
- Keywords
- Volunteer, Safety, Tolerability, AZD8566
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8566Drug
10ml oral solution administered once a day over 10 days. Specific dose will be selected by the safety review committee
PlaceboDrug
10ml oral solution administered once a day over 10 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD8566 |
| 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.
Pharmacokinetic profile: concentration of AZD8566 in blood
Measured: Samples taken during Visit 2 (residential period) at up to 15 defined timepoints pre-dose and post- dose on Day 1 and Day 10
Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events
Measured: Assessments taken at Visit 1 (enrolment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored throughout the study from Visit 1 to Visit 3 for adverse events.
Secondary outcomes (1)
Pharmacokinetic profile: concentration of AZD8566 in urine
Measured: Samples collected over 48 hours from pre-dose to 48 hours post-dose on Day 1 and Day 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Emeline Ramos, MD, Principal investigator, Clinical Pharmacology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844103
- Sponsor's protocol ID
- D1320C00002
- Status last verified
- Apr 2009
- First submitted
- 12 Feb 2009
- Last updated
- 30 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of AZD8566 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00844103
- Acronym / sponsor ID
- D1320C00002
- Conditions
- Pharmacokinetics
- Keywords
- Volunteer, Safety, Tolerability, AZD8566
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 13 Feb 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 purpose of this study is to determine how well tolerated and safe AZD8566 is when given over 10 days, at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD8566 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of written informed consent.
- Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
- Females who are permanently or surgically sterile or postmenopausal and males.
Key exclusion criteria (4 listed)
- Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug
- History of any convulsions or seizures
- History of infection or at risk of infection due to recent surgery or trauma
- History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug
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 |
|---|---|---|
| AZD856610ml oral solution administered once a day over 10 days. Specific dose will be selected by the safety review committee | Drug | 1 |
| Placebo10ml oral solution administered once a day over 10 days. | Drug | 2 |
Primary outcome
Pharmacokinetic profile: concentration of AZD8566 in blood
Time frame: Samples taken during Visit 2 (residential period) at up to 15 defined timepoints pre-dose and post- dose on Day 1 and Day 10
Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events
Time frame: Assessments taken at Visit 1 (enrolment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored throughout the study from Visit 1 to Visit 3 for adverse events.
1 secondary outcome
Pharmacokinetic profile: concentration of AZD8566 in urine
Time frame: Samples collected over 48 hours from pre-dose to 48 hours post-dose on Day 1 and Day 10.
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 Apr 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.
Emeline Ramos, MD principal investigator
Clinical Pharmacology Unit
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 AZD8566 in people with Pharmacokinetics, 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 30 Apr 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. 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?
Pharmacokinetic profile: concentration of AZD8566 in blood (time frame: Samples taken during Visit 2 (residential period) at up to 15 defined timepoints pre-dose and post- dose on Day 1 and Day 10). The study lists 2 primary outcomes in all. 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 Apr 2009.