HealthyPhase 1NCT00957437
Study to Assess Drug Concentrations in Plasma of Different Extended-release Formulations of AZD1305
A Phase 1 study testing AZD1305 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers. 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?
- AZD1305
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Nov 2009
- 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, written and dated informed consent prior to any study specific procedures.
- Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
Who cannot join
- History or presence of any clinically significant disease or disorder in the opinion of the investigator.
- Use of nicotine in the last 4 weeks before screening and not more than 7 cigarettes per week (equivalent to 1 nicotine patch or 7 nicotine gums per week) before then. There will be no smoking until follow-up visit.
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomised, Open, Single-centre Study to Evaluate the Pharmacokinetics of Different Extended-release Formulations of AZD1305 When Given as Single and Repeated Oral Doses to Healthy Male Volunteers
The purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers.
- Conditions
- Healthy
- Being tested
- AZD1305
- Keywords
- Phase 1, healthy volunteer, male, pharmacokinetics, AZD1305
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1305Drug
Single Oral Dose, ER formulation 1
AZD1305Drug
ER formulation 1, bid for 5 days
AZD1305Drug
Single Oral Dose, ER formulation 2
| Study group | Role | What they receive |
|---|---|---|
| Part A: 3 way crossover | Experimental | AZD1305: ER test formulation 1 (w/wo food) and reference formulation Receives: Drug: AZD1305 |
| Part B1: single arm | Experimental | AZD1305: ER test formulation 1 Receives: Drug: AZD1305 |
| Part B2: 3 way crossover | Experimental | AZD1305: ER test formulation 2 (w/wo food) and reference formulation Receives: Drug: AZD1305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma
Measured: From predose until 48 hours post last dose
Secondary outcomes (1)
Adverse Events, ECG variables, vital signs, physical examination, laboratory variables and weight
Measured: Frequent safety measurements during the study, from screening period to follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startAug 2009
- Study completionNov 2009
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Helen Lunde, Study director, AstraZeneca R&D, Mölndal, SwedenKlaus Francke, Principal investigator, PAREXEL Early Phase Clinical Unit, London UK.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957437
- Sponsor's protocol ID
- D3190C00016
- Status last verified
- Nov 2009
- First submitted
- 10 Aug 2009
- Last updated
- 26 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Open, Single-centre Study to Evaluate the Pharmacokinetics of Different Extended-release Formulations of AZD1305 When Given as Single and Repeated Oral Doses to Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00957437
- Acronym / sponsor ID
- D3190C00016
- Conditions
- Healthy
- Keywords
- Phase 1, healthy volunteer, male, pharmacokinetics, AZD1305
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Study completion
- Nov 2009 (actual)
- First posted
- 12 Aug 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 purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: 3 way crossover | Experimental | Drug: AZD1305AZD1305: ER test formulation 1 (w/wo food) and reference formulation |
| Part B1: single arm | Experimental | Drug: AZD1305AZD1305: ER test formulation 1 |
| Part B2: 3 way crossover | Experimental | Drug: AZD1305AZD1305: ER test formulation 2 (w/wo food) and reference formulation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Provision of signed, written and dated informed consent prior to any study specific procedures.
- Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
Key exclusion criteria (3 listed)
- History or presence of any clinically significant disease or disorder in the opinion of the investigator.
- Use of nicotine in the last 4 weeks before screening and not more than 7 cigarettes per week (equivalent to 1 nicotine patch or 7 nicotine gums per week) before then. There will be no smoking until follow-up visit.
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of 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 |
|---|---|---|
| AZD1305Single Oral Dose, ER formulation 1 | Drug | Part A: 3 way crossover |
| AZD1305ER formulation 1, bid for 5 days | Drug | Part B1: single arm |
| AZD1305Single Oral Dose, ER formulation 2 | Drug | Part B2: 3 way crossover |
Primary outcome
Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma
Time frame: From predose until 48 hours post last dose
1 secondary outcome
Adverse Events, ECG variables, vital signs, physical examination, laboratory variables and weight
Time frame: Frequent safety measurements during the study, from screening period to follow-up
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 26 Nov 2009.
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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.
Helen Lunde study director
AstraZeneca R&D, Mölndal, Sweden
Klaus Francke principal investigator
PAREXEL Early Phase Clinical Unit, London UK.
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 AZD1305 in people with Healthy, 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 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 26 Nov 2009. 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. 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?
Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma (time frame: From predose until 48 hours post last dose). 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 26 Nov 2009.