HealthyPhase 1NCT00860353
Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses ofAZD2551
A Phase 1 study testing AZD2551 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine how well tolerated and safe AZD2551 is at different dose levels in healthy, non-smoking males. It will also investigate how quickly AZD2551 is absorbed into and cleared by the body Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD2551
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to May 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed, written and dated informed consent prior to any study specific procedures
- Be willing to use barrier methods of contraception unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods
- Have a body mass index between 18 and 30 kg/m2 inclusive and weight at least 50kg and no more than 100kg
Who cannot join
- Use of any prescribed or non-prescribed medication during the two weeks prior to the administration of study drug
- History or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
- Any impairment of kidney function or laboratory results for markers of kidney function that are outside the reference range and considered clinically significant
- Underlying musculoskeletal symptoms of unknown origin, subjects with shoulder girdle musculoskeletal symptoms or Dupuytrens syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomised, Placebo-controlled, Phase I Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single, Ascending, Oral Doses of AZD2551 in Healthy Male Subjects
The purpose of this study is to determine how well tolerated and safe AZD2551 is at different dose levels in healthy, non-smoking males. It will also investigate how quickly AZD2551 is absorbed into and cleared by the body
- Conditions
- Healthy
- Being tested
- AZD2551, Placebo
- Keywords
- Healthy Volunteer, Single Ascending Dose, Safety, Tolerability, AZD2551, Healthy Volunteer Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2551Drug
Single dose of oral solution.
PlaceboDrug
Single dose of oral solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD2551 |
| 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.
Safety and tolerability of AZD2551 by assessment of vital signs, ECG, laboratory variables and adverse events
Measured: Baseline assessments at Visit 1 (enrolment). Assessments pre-dose and at defined timepoints post-dose at Visit 2. Follow up assessment at Visit 3
Pharmacokinetic profile: concentration of AZD2551 in blood
Measured: Samples taken at Visit 2. Up to 15 samples to be taken at defined timepoints post-dose, plus one sample pre-dose
Secondary outcomes (1)
Pharmacokinetic profile: concentration of AZD2551 in urine
Measured: Samples collected at Visit 2 from pre-dose up to 48 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 posted12 Mar 2009 (estimated)
- Study startFeb 2009
- Study completionMay 2009
Why it stopped: Due to portfolio and logistical issues, this study will not be re-started at the present time. The study is not being terminated for safety reasons.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Fahy, MA, MBBS (Hons), Principal investigator, AstraZeneca Clinical Pharmacology Unit, E Floor, Queens Medical Centre, Nottingham NG7 2UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860353
- Sponsor's protocol ID
- D1570C00001
- Status last verified
- Dec 2010
- First submitted
- 11 Mar 2009
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomised, Placebo-controlled, Phase I Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single, Ascending, Oral Doses of AZD2551 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00860353
- Acronym / sponsor ID
- D1570C00001
- Conditions
- Healthy
- Keywords
- Healthy Volunteer, Single Ascending Dose, Safety, Tolerability, AZD2551, Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to portfolio and logistical issues, this study will not be re-started at the present time. The study is not being terminated for safety reasons.
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Study completion
- May 2009 (actual)
- First posted
- 12 Mar 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 AZD2551 is at different dose levels in healthy, non-smoking males. It will also investigate how quickly AZD2551 is absorbed into and cleared by 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: AZD2551 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of signed, written and dated informed consent prior to any study specific procedures
- Be willing to use barrier methods of contraception unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods
- Have a body mass index between 18 and 30 kg/m2 inclusive and weight at least 50kg and no more than 100kg
Key exclusion criteria (4 listed)
- Use of any prescribed or non-prescribed medication during the two weeks prior to the administration of study drug
- History or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
- Any impairment of kidney function or laboratory results for markers of kidney function that are outside the reference range and considered clinically significant
- Underlying musculoskeletal symptoms of unknown origin, subjects with shoulder girdle musculoskeletal symptoms or Dupuytrens syndrome
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 |
|---|---|---|
| AZD2551Single dose of oral solution. | Drug | 1 |
| PlaceboSingle dose of oral solution | Drug | 2 |
Primary outcome
Safety and tolerability of AZD2551 by assessment of vital signs, ECG, laboratory variables and adverse events
Time frame: Baseline assessments at Visit 1 (enrolment). Assessments pre-dose and at defined timepoints post-dose at Visit 2. Follow up assessment at Visit 3
Pharmacokinetic profile: concentration of AZD2551 in blood
Time frame: Samples taken at Visit 2. Up to 15 samples to be taken at defined timepoints post-dose, plus one sample pre-dose
1 secondary outcome
Pharmacokinetic profile: concentration of AZD2551 in urine
Time frame: Samples collected at Visit 2 from pre-dose up to 48 hours post-dose
Results and safety
The study was stopped early (reason given: Due to portfolio and logistical issues, this study will not be re-started at the present time. The study is not being terminated for safety reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 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.
William Fahy, MA, MBBS (Hons) principal investigator
AstraZeneca Clinical Pharmacology Unit, E Floor, Queens Medical Centre, Nottingham NG7 2UH
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 AZD2551 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: stopped early, as of the sponsor's last update on 3 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 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 was stopped early (reason given: Due to portfolio and logistical issues, this study will not be re-started at the present time. The study is not being terminated for safety reasons.). Results are not available in the source record.
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 AZD2551 by assessment of vital signs, ECG, laboratory variables and adverse events (time frame: Baseline assessments at Visit 1 (enrolment). Assessments pre-dose and at defined timepoints post-dose at Visit 2. Follow up assessment at Visit 3). 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 3 Dec 2010.