HealthyPhase 1NCT01007929
Open-Label Absorption, Distribution, Metabolism, Excretion (ADME) and Pharmacokinetics (PK) Following a Single Oral Dose of AZD1236 in Healthy Male Subjects
A Phase 1 study testing 14C-AZD1236 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this study is to characterise the metabolism, excretion and pharmacokinetics of a single oral dose of [14C] AZD1236 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 50 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 14C-AZD1236
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 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 50 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Non-smokers
Who cannot join
- Subjects who are exposed to radiation exposure as part of their occupation
- Subjects exposed to radiation levels above background of >5 mSv in last year, >10 mSv over last 5 years or a cumulative total of > 1 mSv per year of life
- A history or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion for drugs eg. haematological, gastrointestinal, hepatic or renal disease etc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label. Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of 60 mg of [14C] AZD1236 in Healthy Male Subjects
The purpose of this study is to characterise the metabolism, excretion and pharmacokinetics of a single oral dose of [14C] AZD1236 in healthy male subjects.
- Conditions
- Healthy
- Being tested
- 14C-AZD1236
- Keywords
- ADME, safety, oral solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-AZD1236Drug
Oral solution 1mg/mL
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 14C-AZD1236 Receives: Drug: 14C-AZD1236 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile. Concentration of AZD1236 in plasma
Measured: Before and after dosing
Total Radioactivity
Measured: Before and after dosing
Secondary outcomes (1)
Adverse events, clinical chemistry, haematology, urinalysis, pulse and blood pressure, ECG and physical examination
Measured: Before and after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startOct 2009
- Study completionNov 2009 (estimated)
Why it stopped: Future development of AZD1236 is currently under review by the project team and no new studies will be started until this review is completed.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca CPU Medical Director, Principal investigator, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007929
- Sponsor's protocol ID
- D4260C00010
- Status last verified
- Nov 2009
- First submitted
- 29 Oct 2009
- Last updated
- 20 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label. Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of 60 mg of [14C] AZD1236 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01007929
- Acronym / sponsor ID
- D4260C00010
- Conditions
- Healthy
- Keywords
- ADME, safety, oral solution
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Future development of AZD1236 is currently under review by the project team and no new studies will be started until this review is completed.
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Study completion
- Nov 2009 (estimated)
- First posted
- 5 Nov 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 characterise the metabolism, excretion and pharmacokinetics of a single oral dose of [14C] AZD1236 in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 14C-AZD123614C-AZD1236 |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Non-smokers
Key exclusion criteria (3 listed)
- Subjects who are exposed to radiation exposure as part of their occupation
- Subjects exposed to radiation levels above background of >5 mSv in last year, >10 mSv over last 5 years or a cumulative total of > 1 mSv per year of life
- A history or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion for drugs eg. haematological, gastrointestinal, hepatic or renal disease etc
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 |
|---|---|---|
| 14C-AZD1236Oral solution 1mg/mL | Drug | 1 |
Primary outcome
Pharmacokinetic profile. Concentration of AZD1236 in plasma
Time frame: Before and after dosing
Total Radioactivity
Time frame: Before and after dosing
1 secondary outcome
Adverse events, clinical chemistry, haematology, urinalysis, pulse and blood pressure, ECG and physical examination
Time frame: Before and after dosing
Results and safety
The study was stopped early (reason given: Future development of AZD1236 is currently under review by the project team and no new studies will be started until this review is completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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.
AstraZeneca CPU Medical Director principal investigator
AstraZeneca
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 14C-AZD1236 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: stopped early, as of the sponsor's last update on 20 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 was stopped early (reason given: Future development of AZD1236 is currently under review by the project team and no new studies will be started until this review is completed.). 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?
Pharmacokinetic profile. Concentration of AZD1236 in plasma (time frame: Before and after dosing). The study lists 2 primary outcomes in all. 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 20 Nov 2009; AzTrials last refreshed its copy on 7 Nov 2026.