Healthy VolunteersPhase 1SADNCT00729443
Investigating Safety, Tolerability and Pharmakinetics When Giving Single and Fractionated Doses of AZD3241 to Healthy Volunteers
A Phase 1 study testing AZD3241 in people with Healthy Volunteers, run by AstraZeneca at 1 site in Sweden.
Trial summary
The study is carried out in order to investigate safety, tolerability and pharmacokinetics after administrating single and fractionated doses of AZD3241 to healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AZD3241
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2008to Nov 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of informed consent
- Body Mass Index (BMI) 19 to 30 kg/m2 inclusive
- Clinically normal physical findings, including BP, pulse rate, ECG and laboratory findings, as judged by the investigator
Who cannot join
- Clinically significant illness within the 2 weeks prior to the administration of the investigational product
- Heart rate (resting, recumbent) <50 bmp or >85 bmp
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity as judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Centre, Placebo-Controlled, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD3241 Following Administration of Single Ascending (Part A) and Fractionated Ascending (Part B) Oral Doses to Young Healthy Volunteers
The study is carried out in order to investigate safety, tolerability and pharmacokinetics after administrating single and fractionated doses of AZD3241 to healthy volunteers
- Conditions
- Healthy Volunteers
- Being tested
- AZD3241, Placebo
- Keywords
- Single dose, Phase 1, Safety of AZD3241, tolerability of AZD3241
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3241Drug
single oral dose
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD3241 |
| 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.
General tolerability and safety variables
Measured: 2 weeks
Secondary outcomes (1)
pk
Measured: approximately 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ingemar Bylesjö, Principal investigator, Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729443
- Sponsor's protocol ID
- D0490C00012
- Other IDs
- EudractCT# 2008-002466-62
- Acronym
- SAD
- Status last verified
- Nov 2008
- First submitted
- 4 Aug 2008
- Last updated
- 13 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Placebo-Controlled, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD3241 Following Administration of Single Ascending (Part A) and Fractionated Ascending (Part B) Oral Doses to Young Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00729443
- Acronym / sponsor ID
- SAD / D0490C00012
- Conditions
- Healthy Volunteers
- Keywords
- Single dose, Phase 1, Safety of AZD3241, tolerability of AZD3241
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 7 Aug 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 study is carried out in order to investigate safety, tolerability and pharmacokinetics after administrating single and fractionated doses of AZD3241 to healthy volunteers
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 |
|---|---|---|
| 1 | Experimental | Drug: AZD3241 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of informed consent
- Body Mass Index (BMI) 19 to 30 kg/m2 inclusive
- Clinically normal physical findings, including BP, pulse rate, ECG and laboratory findings, as judged by the investigator
Key exclusion criteria (3 listed)
- Clinically significant illness within the 2 weeks prior to the administration of the investigational product
- Heart rate (resting, recumbent) <50 bmp or >85 bmp
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity 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 |
|---|---|---|
| AZD3241single oral dose | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
General tolerability and safety variables
Time frame: 2 weeks
1 secondary outcome
pk
Time frame: approximately 48 hour
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 Nov 2008.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Ingemar Bylesjö principal investigator
Astrazeneca Clinical Pharmacology Unit, Stockholm, Sweden
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 AZD3241 in people with Healthy Volunteers, 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 3 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 Nov 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?
General tolerability and safety variables (time frame: 2 weeks). 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 Nov 2008.