HealthyPhase 1NCT01264250
A Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Volunteers
A Phase 1 study testing AZD2927 in people with Healthy, run by AstraZeneca at 1 site in Sweden.
Trial summary
In this early phase study, healthy male volunteers will be randomly assigned to one dose of either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and Pharmacokinetics of AZD2927. 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?
- AZD2927
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2011to May 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy male subjects aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture
- Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the Investigational Product (IP)
- Have a body mass index (BMI) between 19.0 and 30.0 kg/m2 and weight of at least 50.0 kg and no more than 100.0 kg
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, mental, cardiac, hepatic or renal disorder, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Abnormal vital signs, after 10 minutes supine rest
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IP
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-centre, Single-blind, Randomised, Placebo-controlled, Single-dose Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Subjects
In this early phase study, healthy male volunteers will be randomly assigned to one dose of either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and Pharmacokinetics of AZD2927.
- Conditions
- Healthy
- Being tested
- AZD2927, Placebo
- Keywords
- Safety, Tolerability, pharmacokinetics, drug metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2927Drug
Single dose of AZD2927
PlaceboDrug
Single dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD2927 |
| 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 AZD2927, at screening
Measured: Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables at screening
Safety and tolerability of AZD2927, day 1
Measured: Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables on day 1.
Safety and tolerability of AZD2927, day 2
Measured: Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab on day 2.
Safety and tolerability of AZD2927, day 3
Measured: Monitoring of Adverse events, Electrocardiograms, vital signs, and safety lab on day 3.
Safety and tolerability of AZD2927, at follow up
Measured: Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab at follow up.
Secondary outcomes (3)
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 1
Measured: Pharmacokinetic sampling will be performed day 1
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 2
Measured: Pharmacokinetic sampling will be performed day 2
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 3
Measured: Pharmacokinetic sampling will be performed day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionMay 2011
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wolfgang Kühn, MD, Principal investigator, Quintiles ABHelen Lunde, MD, Study director, AstraZenecaMirjana Kujacic, MD, Principal investigator, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264250
- Sponsor's protocol ID
- D4120C00001
- Status last verified
- May 2011
- First submitted
- 7 Dec 2010
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-centre, Single-blind, Randomised, Placebo-controlled, Single-dose Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01264250
- Acronym / sponsor ID
- D4120C00001
- Conditions
- Healthy
- Keywords
- Safety, Tolerability, pharmacokinetics, drug metabolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Dec 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.
In this early phase study, healthy male volunteers will be randomly assigned to one dose of either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and Pharmacokinetics of AZD2927.
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: AZD2927 |
| 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 (4 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy male subjects aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture
- Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the Investigational Product (IP)
- Have a body mass index (BMI) between 19.0 and 30.0 kg/m2 and weight of at least 50.0 kg and no more than 100.0 kg
Key exclusion criteria (5 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, mental, cardiac, hepatic or renal disorder, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Abnormal vital signs, after 10 minutes supine rest
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IP
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results 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 |
|---|---|---|
| AZD2927Single dose of AZD2927 | Drug | 1 |
| PlaceboSingle dose of placebo | Drug | 2 |
Primary outcome
Safety and tolerability of AZD2927, at screening
Time frame: Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables at screening
Safety and tolerability of AZD2927, day 1
Time frame: Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables on day 1.
Safety and tolerability of AZD2927, day 2
Time frame: Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab on day 2.
Safety and tolerability of AZD2927, day 3
Time frame: Monitoring of Adverse events, Electrocardiograms, vital signs, and safety lab on day 3.
Safety and tolerability of AZD2927, at follow up
Time frame: Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab at follow up.
3 secondary outcomes
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 1
Time frame: Pharmacokinetic sampling will be performed day 1
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 2
Time frame: Pharmacokinetic sampling will be performed day 2
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 3
Time frame: Pharmacokinetic sampling will be performed day 3
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 24 May 2011.
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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.
Wolfgang Kühn, MD principal investigator
Quintiles AB
Helen Lunde, MD study director
AstraZeneca
Mirjana Kujacic, MD principal investigator
AstraZeneca
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 AZD2927 in people with Healthy, run by AstraZeneca at 1 site in Sweden.
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 4 inclusion and 5 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 24 May 2011. 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 Sweden. 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?
Safety and tolerability of AZD2927, at screening (time frame: Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables at screening). The study lists 5 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 24 May 2011.