Part A Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 Years.Phase 1NCT01148095
To Investigate the Safety, Tolerability and Pharmacokinetics of AZD2516 After Multiple Dosing in Healthy Volunteers
A Phase 1 study testing AZD2516 in people with Part A Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 Years. and Part B Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 and Elderly Volunteers Aged 60 to 80, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
AZD2516 is being developed for the oral treatment of chronic neuropathic pain. This study is split in to two parts. Part A will measure the effect of food and a new formulation of the drug in the blood and see how well it is tolerated. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Part A Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 Years., Part B Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 and Elderly Volunteers Aged 60 to 80
- 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
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Jul 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- Healthy volunteers able and willing to comply with all study requirements.
Who cannot join
- An ongoing or history of a medical or psychiatric disease/condition which may put the healthy volunteer at risk or interfere with the study objectives because of participation in the study, as judged by the investigator(s).
- History of psychotic disorder among first degree relatives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre Two Part Randomized Phase I Study to Assess the Pharmacokinetics of an ER Formulation of AZD2516 and to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 After Multiple Ascending Doses in Healthy Volunteers
AZD2516 is being developed for the oral treatment of chronic neuropathic pain. This study is split in to two parts. Part A will measure the effect of food and a new formulation of the drug in the blood and see how well it is tolerated. Part B will commence after the completion of Part A and will investigate the safety and tolerability of daily dosing with AZD2516.
- Conditions
- Part A Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 Years., Part B Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 and Elderly Volunteers Aged 60 to 80
- Being tested
- AZD2516, Placebo
- Keywords
- AZD2516, Phase 1, Healthy volunteer, pharmacokinetics, safety, tolerability, Multiple ascending doses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2516Drug
Oral, single, daily, 11 days
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD2516 (dose escalating) Receives: Drug: AZD2516 |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events, vital signs
Measured: Day -1 until follow-up
Secondary outcomes (3)
Maximum plasma concentration (Cmax)
Measured: Day 1 - Day 12
Time to Cmax (tmax)
Measured: Day 1 - Day 12
Terminal rate constant (λz)
Measured: Day 1 - Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Part A Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 Years.Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Investigators
- Darren Wilbraham, MBBS, DCPSA, Principal investigator, Quintiles Drug Research Unit 6, Newcomen Street, London, SE1 1YR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148095
- Sponsor's protocol ID
- D2080C00002
- Status last verified
- Feb 2011
- First submitted
- 18 Jun 2010
- Last updated
- 8 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Two Part Randomized Phase I Study to Assess the Pharmacokinetics of an ER Formulation of AZD2516 and to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 After Multiple Ascending Doses in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01148095
- Acronym / sponsor ID
- D2080C00002
- Conditions
- Part A Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 Years., Part B Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 and Elderly Volunteers Aged 60 to 80
- Keywords
- AZD2516, Phase 1, Healthy volunteer, pharmacokinetics, safety, tolerability, Multiple ascending doses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Jun 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 22 Jun 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.
AZD2516 is being developed for the oral treatment of chronic neuropathic pain. This study is split in to two parts. Part A will measure the effect of food and a new formulation of the drug in the blood and see how well it is tolerated. Part B will commence after the completion of Part A and will investigate the safety and tolerability of daily dosing with AZD2516.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD2516AZD2516 (dose escalating) |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- Healthy volunteers able and willing to comply with all study requirements.
Key exclusion criteria (2 listed)
- An ongoing or history of a medical or psychiatric disease/condition which may put the healthy volunteer at risk or interfere with the study objectives because of participation in the study, as judged by the investigator(s).
- History of psychotic disorder among first degree relatives.
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 |
|---|---|---|
| AZD2516Oral, single, daily, 11 days | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
Adverse Events, vital signs
Time frame: Day -1 until follow-up
3 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Day 1 - Day 12
Time to Cmax (tmax)
Time frame: Day 1 - Day 12
Terminal rate constant (λz)
Time frame: Day 1 - Day 12
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 8 Feb 2011.
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.
Darren Wilbraham, MBBS, DCPSA principal investigator
Quintiles Drug Research Unit 6, Newcomen Street, London, SE1 1YR
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 Part A Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 Years. and Part B Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 and Elderly Volunteers Aged 60 to 80, 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 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 8 Feb 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 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?
Adverse Events, vital signs (time frame: Day -1 until follow-up). 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 8 Feb 2011.