HealthyPhase 1NCT00754715
Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers
A Phase 1 study testing AZD2516 in people with Healthy, run by AstraZeneca at 1 site in Sweden.
Trial summary
The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD2516
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2008to Dec 2008
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy white males or non-fertile females between 20 to 45 years and 65 to 80 years old.
- Weight between 50 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2
Who cannot join
- History of previous or ongoing psychiatric disease.
- Abnormalities in ECG that may interfere with interpretation of data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-Controlled Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 in Young and Elderly Healthy Volunteers After Oral Single Ascending Doses
The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose.
- Conditions
- Healthy
- Being tested
- AZD2516, Placebo
- Keywords
- Multiple dosing study,, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2516Drug
Solution administered once orally
PlaceboDrug
Solution administered only once
| Study group | Role | What they receive |
|---|---|---|
| AZD2516 | Experimental | Not described Receives: Drug: AZD2516 |
| Placebo | 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 AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
Measured: From first to last visit
Secondary outcomes (2)
Safety and tolerability of AZD2516 by assessment of non-serious adverse events
Measured: Collected from start of residential period until last visit.
Determine the single ascending dose pharmacokinetics of AZD2516
Measured: PK sampling taken at defined timepoints during residential period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2008
- Study completionDec 2008
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bo Fransson, MD, Principal investigator, AstraZenecaLars Ståhle, MD, PhD, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754715
- Sponsor's protocol ID
- D2080C00001
- Other IDs
- EudractCT: 2008-003598-42
- Status last verified
- Dec 2008
- First submitted
- 16 Sep 2008
- Last updated
- 15 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-Controlled Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 in Young and Elderly Healthy Volunteers After Oral Single Ascending Doses
- ClinicalTrials.gov ID
- NCT00754715
- Acronym / sponsor ID
- D2080C00001
- Conditions
- Healthy
- Keywords
- Multiple dosing study,, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Sep 2008 (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 purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD2516 | Experimental | Drug: AZD2516 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy white males or non-fertile females between 20 to 45 years and 65 to 80 years old.
- Weight between 50 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2
Key exclusion criteria (2 listed)
- History of previous or ongoing psychiatric disease.
- Abnormalities in ECG that may interfere with interpretation of data.
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 |
|---|---|---|
| AZD2516Solution administered once orally | Drug | AZD2516 |
| PlaceboSolution administered only once | Drug | Placebo |
Primary outcome
Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
Time frame: From first to last visit
2 secondary outcomes
Safety and tolerability of AZD2516 by assessment of non-serious adverse events
Time frame: Collected from start of residential period until last visit.
Determine the single ascending dose pharmacokinetics of AZD2516
Time frame: PK sampling taken at defined timepoints during residential period
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 15 Dec 2008.
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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.
Bo Fransson, MD principal investigator
AstraZeneca
Lars Ståhle, MD, PhD study chair
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 AZD2516 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 2 inclusion and 2 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 15 Dec 2008. 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 AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables (time frame: From first to last visit). 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 15 Dec 2008.