HealthyPhase 12007-005765-38NCT00689403
Evaluate Different Extended-release (ER) Tablets/Capsules of AZD1305
A Phase 1 study testing AZD1305 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
To study the properties of different tablets/capsules of AZD1305 in healthy male volunteers. 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
- 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
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to Jul 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male between the age of 20 - 45
- Non-smoking
Who cannot join
- Potassium outside normal reference values
- ECG findings outside normal range
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Two-part, Randomised, Open, Single-centre, Crossover Study to Evaluate Different Extended-release Formulations of AZD1305 When Given as Single Oral Doses to Healthy Male Volunteers
To study the properties of different tablets/capsules of AZD1305 in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- AZD1305
- Keywords
- AZD1305, pharmacokinetics, Properties of different ER formulations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1305Drug
Extended release capsules, oral single doses
AZD1305Drug
Extended release capsules, oral single doses
| Study group | Role | What they receive |
|---|---|---|
| Part A: 2x2 crossover | Experimental | 4 different AZD1305 ER formulations Receives: Drug: AZD1305 |
| Part B: 3x3 crossover | Experimental | 2 different AZD1305 ER formulations and a reference formulation Receives: Drug: AZD1305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic variables
Measured: During all dosing visits
Secondary outcomes (1)
Adverse events, ECG, safety laboratory, vital signs, physical examination
Measured: During the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2008
- Study completionJul 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Helen Lunde, MD, Study director, AstraZeneca R&D, Mölndal, SwedenDaniel Bradford, MD, MA, MBBS, DCPSA, Principal investigator, PAREXEL Clinical Pharmacology Research UnitHarrow, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689403
- Sponsor's protocol ID
- D3190C00014
- Acronym
- 2007-005765-38
- Status last verified
- Dec 2010
- First submitted
- 30 May 2008
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Two-part, Randomised, Open, Single-centre, Crossover Study to Evaluate Different Extended-release Formulations of AZD1305 When Given as Single Oral Doses to Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00689403
- Acronym / sponsor ID
- 2007-005765-38 / D3190C00014
- Conditions
- Healthy
- Keywords
- AZD1305, pharmacokinetics, Properties of different ER formulations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 3 Jun 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.
To study the properties of different tablets/capsules of AZD1305 in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: 2x2 crossover | Experimental | Drug: AZD13054 different AZD1305 ER formulations |
| Part B: 3x3 crossover | Experimental | Drug: AZD13052 different AZD1305 ER formulations and a reference formulation |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male between the age of 20 - 45
- Non-smoking
Key exclusion criteria (2 listed)
- Potassium outside normal reference values
- ECG findings outside normal range
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 |
|---|---|---|
| AZD1305Extended release capsules, oral single doses | Drug | Part A: 2x2 crossover |
| AZD1305Extended release capsules, oral single doses | Drug | Part B: 3x3 crossover |
Primary outcome
Pharmacokinetic variables
Time frame: During all dosing visits
1 secondary outcome
Adverse events, ECG, safety laboratory, vital signs, physical examination
Time frame: During the study
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 3 Dec 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.
Helen Lunde, MD study director
AstraZeneca R&D, Mölndal, Sweden
Daniel Bradford, MD, MA, MBBS, DCPSA principal investigator
PAREXEL Clinical Pharmacology Research UnitHarrow, United Kingdom
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 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 3 Dec 2010. 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 (time frame: During all dosing visits). 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 3 Dec 2010.