HealthyPhase 1NCT00689039
Study of an Extended Release (ER) Tablet, Single and Repeated Dosing
A Phase 1 study testing AZD1305 in people with Healthy, run by AstraZeneca at 1 site in Sweden.
Trial summary
The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how the medication is metabolised by the body (how it is taken up, distributed, and how it disappears from the body). The study is performed in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy 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?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2007to 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
- Clinically normal physical findings, laboratory values and resting ECG as judged by the investigator
Who cannot join
- ECG findings outside normal range
- Potassium outside normal reference values
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-part, Single-centre, Open (Part A) Single Blind (Part B), Randomised, Placebo-controlled Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Doses With and Without Food and Multiple Ascending Oral Doses of AZD1305 Extended-release Tablet in Healthy & Elderly Subj
The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how the medication is metabolised by the body (how it is taken up, distributed, and how it disappears from the body). The study is performed in healthy volunteers.
- Conditions
- Healthy
- Being tested
- AZD1305, Placebo
- Keywords
- AZD1305, safety, pharmacokinetics, multiple ascending doses, Safety and pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1305Drug
ER tablet, administered as single and repeated doses.
PlaceboDrug
Tablet, administered as single and repeated doses.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | AZD1305 ER tablet Receives: Drug: AZD1305 |
| B | Placebo comparator | Placebo tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight
Measured: During the study
Secondary outcomes (1)
Pharmacokinetic variables
Measured: During all dosing visits
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 startApr 2007
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Helen Lunde, MD, Study director, AstraZeneca R&D, Mölndal, SwedenMarianne Hartford, MD, PhD, Principal investigator, AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689039
- Sponsor's protocol ID
- D3190C00004
- Other IDs
- 2006-006356-35 (EudraCT No)
- 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 Two-part, Single-centre, Open (Part A) Single Blind (Part B), Randomised, Placebo-controlled Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Doses With and Without Food and Multiple Ascending Oral Doses of AZD1305 Extended-release Tablet in Healthy & Elderly Subj
- ClinicalTrials.gov ID
- NCT00689039
- Acronym / sponsor ID
- D3190C00004
- Conditions
- Healthy
- Keywords
- AZD1305, safety, pharmacokinetics, multiple ascending doses, Safety and pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- 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.
The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how the medication is metabolised by the body (how it is taken up, distributed, and how it disappears from the body). The study is performed in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AZD1305AZD1305 ER tablet |
| B | Placebo comparator | Drug: PlaceboPlacebo tablet |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
- Clinically normal physical findings, laboratory values and resting ECG as judged by the investigator
Key exclusion criteria (2 listed)
- ECG findings outside normal range
- Potassium outside normal reference values
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 |
|---|---|---|
| AZD1305ER tablet, administered as single and repeated doses. | Drug | A |
| PlaceboTablet, administered as single and repeated doses. | Drug | B |
Primary outcome
Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight
Time frame: During the study
1 secondary outcome
Pharmacokinetic variables
Time frame: During all dosing visits
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
Marianne Hartford, MD, PhD principal investigator
AstraZeneca, Clinical Pharmacology Unit at Sahlgrenska University Hospital, 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 AZD1305 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 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 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?
Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight (time frame: During the study). 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.