Healthy MenPhase 1NCT00935662
A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses
A Phase 1 study testing AZD8329 in people with Healthy Men, run by AstraZeneca at 2 sites in Sweden.
Trial summary
The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men
- What is being tested?
- AZD8329
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 2 sitesSweden
- Study dates
- Jul 2009to Aug 2010
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg
Who cannot join
- 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 result of the study, or the subject´s ability to participate
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomised, Single-blind, Placebo-controlled, Two-centre Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD8329 After Single Ascending Oral Doses
The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.
- Conditions
- Healthy Men
- Being tested
- AZD8329, Placebo
- Keywords
- First time in man, Safety study, AZD8329
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8329Drug
Oral solution, single ascending doses
PlaceboDrug
Oral solution, placebo
| Study group | Role | What they receive |
|---|---|---|
| AZD8329 | Experimental | AZD8329 oral solution Receives: Drug: AZD8329 |
| Placebo | Placebo comparator | Placebo for AZD8329 oral solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)
Measured: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.
Secondary outcomes (1)
PK samples for AZD8329
Measured: Intense PK-sampling during the 24 hours following administration of investigational product and additional samples up to 72 hours after dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MenStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wolfgang Kühn, Principal investigator, Quintiles AB, Phase I Services, Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935662
- Sponsor's protocol ID
- D2350C00001
- Other IDs
- EudraCT No. 2009-010702-11
- Status last verified
- Sep 2010
- First submitted
- 7 Jul 2009
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-blind, Placebo-controlled, Two-centre Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD8329 After Single Ascending Oral Doses
- ClinicalTrials.gov ID
- NCT00935662
- Acronym / sponsor ID
- D2350C00001
- Conditions
- Healthy Men
- Keywords
- First time in man, Safety study, AZD8329
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 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 primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD8329 | Experimental | Drug: AZD8329AZD8329 oral solution |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for AZD8329 oral solution |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Provision of informed consent prior to any study specific procedures
- Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg
Key exclusion criteria (3 listed)
- 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 result of the study, or the subject´s ability to participate
- Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
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 |
|---|---|---|
| AZD8329Oral solution, single ascending doses | Drug | AZD8329 |
| PlaceboOral solution, placebo | Drug | Placebo |
Primary outcome
Safety measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)
Time frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.
1 secondary outcome
PK samples for AZD8329
Time frame: Intense PK-sampling during the 24 hours following administration of investigational product and additional samples up to 72 hours after 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 13 Sep 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.
Wolfgang Kühn principal investigator
Quintiles AB, Phase I Services, Uppsala, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD8329 in people with Healthy Men, run by AstraZeneca at 2 sites 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 2 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 13 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events) (time frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.). 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 13 Sep 2010.