HealthyPhase 1NCT00752830
To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328
A Phase 1 study testing AZD0328 in people with Healthy, run by AstraZeneca at 1 site in Sweden.
Trial summary
The purpose of the study is to evaluate the effect of food on the pharmacokinetics of AZD0328 in healthy male volunteers. AZD0328 will be administered as a single oral dose (capsule) during two treatment periods, after food intake or during fasting condition. 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?
- AZD0328
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2008to Oct 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 Caucasian subjects.
- Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.
- Signed informed consent form
Who cannot join
- History of clinically significant cardio or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder (including dyspepsia or GERD) or any other major disorder that may interfere with the study.
- Intake of another investigational drug or participation in another study which may interfere with the objectives of the study, within 12 weeks before the administration of the investigational product.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open, Randomized, Single-Dose, Two-Treatment (Fed Versus Fasting), Two-Period Cross-Over Single-Centre Study to Evaluate the Effect of Food on the Pharmacokinetics of AZD0328 Following Oral Administration (Capsule) in Healthy Male Subjects
The purpose of the study is to evaluate the effect of food on the pharmacokinetics of AZD0328 in healthy male volunteers. AZD0328 will be administered as a single oral dose (capsule) during two treatment periods, after food intake or during fasting condition.
- Conditions
- Healthy
- Being tested
- AZD0328
- Keywords
- AZD0328, Food Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0328Drug
Oral capsule, single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD0328 administration during fasting condition Receives: Drug: AZD0328 |
| 2 | Experimental | AZD0328 administration after food intake Receives: Drug: AZD0328 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK variables
Measured: Several PK samples during the study days
Secondary outcomes (1)
Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs)
Measured: During the whole treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2008
- Study completionOct 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Didier Meulien, MD, Study director, AstraZeneca R&D Södertälje, SwedenGabriella Samuelsson Palmgren, MD, Principal investigator, AstraZeneca Clinical Pharmacology Unit, AstraZeneca R&D Lund,Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752830
- Sponsor's protocol ID
- D0190C00009
- Other IDs
- EUdract NO 2008-003691-22
- Status last verified
- Oct 2008
- First submitted
- 12 Sep 2008
- Last updated
- 29 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open, Randomized, Single-Dose, Two-Treatment (Fed Versus Fasting), Two-Period Cross-Over Single-Centre Study to Evaluate the Effect of Food on the Pharmacokinetics of AZD0328 Following Oral Administration (Capsule) in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00752830
- Acronym / sponsor ID
- D0190C00009
- Conditions
- Healthy
- Keywords
- AZD0328, Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 15 Sep 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 of the study is to evaluate the effect of food on the pharmacokinetics of AZD0328 in healthy male volunteers. AZD0328 will be administered as a single oral dose (capsule) during two treatment periods, after food intake or during fasting condition.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD0328AZD0328 administration during fasting condition |
| 2 | Experimental | Drug: AZD0328AZD0328 administration after food intake |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male Caucasian subjects.
- Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.
- Signed informed consent form
Key exclusion criteria (2 listed)
- History of clinically significant cardio or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder (including dyspepsia or GERD) or any other major disorder that may interfere with the study.
- Intake of another investigational drug or participation in another study which may interfere with the objectives of the study, within 12 weeks before the administration of the investigational product.
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 |
|---|---|---|
| AZD0328Oral capsule, single dose | Drug | 1, 2 |
Primary outcome
PK variables
Time frame: Several PK samples during the study days
1 secondary outcome
Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs)
Time frame: During the whole treatment period
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 29 Oct 2008.
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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.
Didier Meulien, MD study director
AstraZeneca R&D Södertälje, Sweden
Gabriella Samuelsson Palmgren, MD principal investigator
AstraZeneca Clinical Pharmacology Unit, AstraZeneca R&D Lund,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 AZD0328 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 3 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 29 Oct 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. 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?
PK variables (time frame: Several PK samples during the study days). 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 29 Oct 2008.