AbsorptionPhase 1NCT00940641
Assess the Absorption, Distribution, Metabolism and Excretion of AZD7325 After Intravenous and Oral Administration
A Phase 1 study testing AZD7325 in people with Absorption and Distribution, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the absorption, distribution, metabolism and excretion of AZD7325 after intravenous and 14C labeled oral dose Read more about this study
- Who is it for?
- Ages 35 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Absorption, Distribution, Metabolism
- What is being tested?
- AZD7325
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Oct 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 35 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects Day 1
- Body Mass Index (BMI) > 18 and < 30kg/m2
Who cannot join
- Clinically relevant disease and abnormalities (past or present) which in the opinion of the investigator, may either put the subject at risk to participate in this study or may influence the results of the study or the subject's ability to participate in the study
- Use of prescription medication within 14 days of the first dose of the investigational product
- Blood loss in excess of 200 mL within 30 days of Day-1 in excess of 500 mL within 90 days of Day-1 or in excess of 1350 mL within 1 year of Day-1 or donation of blood products within 14 days of Day -1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open, Two Period, Single-Centre, Study to Assess Absorption, Distribution, Metabolism and Excretion (ADME) After Intravenous and 14C-labelled Oral Administration of AZD7325 to Healthy Male Volunteers
The purpose of this study is to evaluate the absorption, distribution, metabolism and excretion of AZD7325 after intravenous and 14C labeled oral dose
- Conditions
- Absorption, Distribution, Metabolism, Excretion
- Being tested
- AZD7325
- Keywords
- Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7325Drug
IV Dose
AZD7325Drug
oral dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | IV dose of AZD7325 Receives: Drug: AZD7325 |
| 2 | Experimental | 14C oral dose of AZD7325 Receives: Drug: AZD7325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess absorption, distribution, metabolism and excretion of AZD7325 after IV dose and 14C oral dose administration
Measured: Daily
Secondary outcomes (1)
To evaluate safety and tolerability after a single oral administration of [14C] AZD7325 and after a single intravenous administration of non radio-labelled AZD7325
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2009 (estimated)
- Study completionOct 2009 (estimated)
Why it stopped: Study withdrawn prior to enrollment due to AZ business decision unrelated to safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbsorptionStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Raj Chetty, MBBS, MD, FRCPath., Principal investigator, AstraZeneca Alderly Park CPU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940641
- Sponsor's protocol ID
- D1140C00017
- Status last verified
- Jan 2011
- First submitted
- 15 Jul 2009
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open, Two Period, Single-Centre, Study to Assess Absorption, Distribution, Metabolism and Excretion (ADME) After Intravenous and 14C-labelled Oral Administration of AZD7325 to Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00940641
- Acronym / sponsor ID
- D1140C00017
- Conditions
- Absorption, Distribution, Metabolism, Excretion
- Keywords
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study withdrawn prior to enrollment due to AZ business decision unrelated to safety.
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 16 Jul 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 absorption, distribution, metabolism and excretion of AZD7325 after intravenous and 14C labeled oral dose
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD7325IV dose of AZD7325 |
| 2 | Experimental | Drug: AZD732514C oral dose of AZD7325 |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects Day 1
- Body Mass Index (BMI) > 18 and < 30kg/m2
Key exclusion criteria (3 listed)
- Clinically relevant disease and abnormalities (past or present) which in the opinion of the investigator, may either put the subject at risk to participate in this study or may influence the results of the study or the subject's ability to participate in the study
- Use of prescription medication within 14 days of the first dose of the investigational product
- Blood loss in excess of 200 mL within 30 days of Day-1 in excess of 500 mL within 90 days of Day-1 or in excess of 1350 mL within 1 year of Day-1 or donation of blood products within 14 days of Day -1
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 |
|---|---|---|
| AZD7325IV Dose | Drug | 1 |
| AZD7325oral dose | Drug | 2 |
Primary outcome
To assess absorption, distribution, metabolism and excretion of AZD7325 after IV dose and 14C oral dose administration
Time frame: Daily
1 secondary outcome
To evaluate safety and tolerability after a single oral administration of [14C] AZD7325 and after a single intravenous administration of non radio-labelled AZD7325
Time frame: Daily
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
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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.
Raj Chetty, MBBS, MD, FRCPath. principal investigator
AstraZeneca Alderly Park CPU
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 AZD7325 in people with Absorption and Distribution, 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: paused, as of the sponsor's last update on 24 Jan 2011. 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?
Results are not available in the source record.
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?
To assess absorption, distribution, metabolism and excretion of AZD7325 after IV dose and 14C oral dose administration (time frame: Daily). 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 24 Jan 2011.