HealthyPhase 1NCT01284595
Healthy Volunteers, Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] AZD8931
A Phase 1 study testing [14C] AZD8931 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
Study to Assess the Absorption, Metabolism and Excretion of [14C]AZD8931 after a Single-Dose Oral Administration 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] AZD8931
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to May 2011
- 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
- Have a body mass index (BMI) of ≥19 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg.
- Regular daily bowel movements (ie, production of at least 1 stool per day).
- Non-smokers or ex-smokers who have stopped smoking for >3 months before Visit 1 and have not used nicotine products for >3 months
- Healthy Male volunteers aged 50 to 65 years, inclusive
Who cannot join
- Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of >5 mSv in the last year, >10 mSv in the last 5 years, or a cumulative total of >1 mSv per year of life
- Participation in any prior radiolabelled study within 12 months of the screening visit (Visit 1).
- History of alcohol abuse or excessive intake of alcohol defined as regular weekly intake of 28 units of alcohol or more (1 unit=25 mL spirits, 125 mL wine, 250 mL beer or lager)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: [14C] AZD8931 - A Phase I, Open Label Study of the Absorption, Metabolism, Excretion, and Pharmacokinetics Following a Single Oral Dose to Healthy Male Subjects
Study to Assess the Absorption, Metabolism and Excretion of [14C]AZD8931 after a Single-Dose Oral Administration
- Conditions
- Healthy
- Being tested
- [14C] AZD8931
- Keywords
- Radioactive carbon, Absorption, Distribution, Metabolism, Excretion, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] AZD8931Drug
Single 160 mg oral dose administered on Day 1
| Study group | Role | What they receive |
|---|---|---|
| AZD8931 | Experimental | [14C] AZD8931 Receives: Drug: [14C] AZD8931 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the absorption, distribution, metabolism and excretion of AZD931 in human subjects
Measured: Multiple blood , urine and faecal samples from pre-dose until 240 hours post last dose
To investigate the pharmacokinetic variable of AZD8931 in plasma
Measured: Multiple PK blood samples from pre-dose until 240 hours post last dose
Secondary outcomes (2)
To investigate the safety and tolerability of AZD8931 given orally
Measured: Frequent safety measurements during the study from screening period to follow-up
To investigate the AZD8931 metabolites variables in plasma
Measured: Multiple PK blood samples from pre-dose until 240 hours post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darren Wilbraham, MBBS, DCPSA, Principal investigator, Quintiles Drug Research Unit at Guy's HospitalMary Stuart, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284595
- Sponsor's protocol ID
- D0102C00007
- Status last verified
- Aug 2014
- First submitted
- 26 Jan 2011
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ballard P, Swaisland HC, Malone MD, Sarda S, Ghiorghiu S, Wilbraham D. Metabolic disposition of AZD8931, an oral equipotent inhibitor of EGFR, HER2 and HER3 signalling, in rat, dog and man. Xenobiotica. 2014 Dec;44(12):1083-98. doi: 10.3109/00498254.2014.938257. Epub 2014 Jul 9.
PubMed 25007130
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [14C] AZD8931 - A Phase I, Open Label Study of the Absorption, Metabolism, Excretion, and Pharmacokinetics Following a Single Oral Dose to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01284595
- Acronym / sponsor ID
- D0102C00007
- Conditions
- Healthy
- Keywords
- Radioactive carbon, Absorption, Distribution, Metabolism, Excretion, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Jan 2011 (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.
Study to Assess the Absorption, Metabolism and Excretion of [14C]AZD8931 after a Single-Dose Oral Administration
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD8931 | Experimental | Drug: [14C] AZD8931[14C] AZD8931 |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a body mass index (BMI) of ≥19 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg.
- Regular daily bowel movements (ie, production of at least 1 stool per day).
- Non-smokers or ex-smokers who have stopped smoking for >3 months before Visit 1 and have not used nicotine products for >3 months
- Healthy Male volunteers aged 50 to 65 years, inclusive
Key exclusion criteria (3 listed)
- Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of >5 mSv in the last year, >10 mSv in the last 5 years, or a cumulative total of >1 mSv per year of life
- Participation in any prior radiolabelled study within 12 months of the screening visit (Visit 1).
- History of alcohol abuse or excessive intake of alcohol defined as regular weekly intake of 28 units of alcohol or more (1 unit=25 mL spirits, 125 mL wine, 250 mL beer or lager)
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] AZD8931Single 160 mg oral dose administered on Day 1 | Drug | AZD8931 |
Primary outcome
To investigate the absorption, distribution, metabolism and excretion of AZD931 in human subjects
Time frame: Multiple blood , urine and faecal samples from pre-dose until 240 hours post last dose
To investigate the pharmacokinetic variable of AZD8931 in plasma
Time frame: Multiple PK blood samples from pre-dose until 240 hours post last dose
2 secondary outcomes
To investigate the safety and tolerability of AZD8931 given orally
Time frame: Frequent safety measurements during the study from screening period to follow-up
To investigate the AZD8931 metabolites variables in plasma
Time frame: Multiple PK blood samples from pre-dose until 240 hours post last dose
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 13 Aug 2014.
- Derived from this study: PubMed 25007130Ballard P, Swaisland HC, Malone MD, Sarda S, Ghiorghiu S, Wilbraham D. Metabolic disposition of AZD8931, an oral equipotent inhibitor of EGFR, HER2 and HER3 signalling, in rat, dog and man. Xenobiotica. 2014 Dec;44(12):1083-98. doi: 10.3109/00498254.2014.938257. Epub 2014 Jul 9.
- Clinical\_Study\_Protocol\_redactedLink provided by the sponsor.
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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.
Darren Wilbraham, MBBS, DCPSA principal investigator
Quintiles Drug Research Unit at Guy's Hospital
Mary Stuart study director
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] AZD8931 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 4 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: finished, as of the sponsor's last update on 13 Aug 2014. 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?
To investigate the absorption, distribution, metabolism and excretion of AZD931 in human subjects (time frame: Multiple blood , urine and faecal samples from pre-dose until 240 hours post last dose). 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?
On the ClinicalTrials.gov record for NCT01284595, which also lists 1 linked publication.
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 13 Aug 2014.