PainPhase 1NCT00832169
Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386
A Phase 1 study testing AZD1386 in people with Pain, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers. 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
- Pain
- What is being tested?
- AZD1386
- 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
- Jan 2009to Feb 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
- Body Mass Index of 18 - 30 and weight of 50 to 100 kilos.
- Healthy volunteer must have regular bowel movements (at least once daily)
Who cannot join
- History of psychiatric or somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator.
- A family history of short QT syndrome or sudden cardiac death amongst first degree relatives.
- Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolism and Pharmacokinetics Following Oral Administration of [14C]AZD1386 to Healthy Male Volunteers
The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.
- Conditions
- Pain
- Being tested
- AZD1386
- Keywords
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1386Drug
1 dose of oral solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD1386 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386
Measured: Until >90% of predicted total radioactivity has been recovered
Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta
Measured: Predose, + postdose 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144hPredose + postdose 1h, 4h, 8h, 24h for excreta from predose (baseline) + postdose from 0h continously until 144h
Secondary outcomes (2)
AZD1386 metabolites in plasma+excreta if feasable
Measured: Predose, 1h, 4h, 8h 24h
Safety + tolerability of AZD1386
Measured: Predose, 2h, 6h, 12h, 24h, 48h, 168h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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)
- Investigators
- Raj Chetty, MD, Principal investigator, AstraZeneca R&D, CPU Alderley Park, UKLars Ståhle, MD, Study chair, AstraZeneca R&D, Södertälje, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832169
- Sponsor's protocol ID
- D5090C00015
- Other IDs
- EudractCT: 2008-006552-22
- Status last verified
- Apr 2009
- First submitted
- 29 Jan 2009
- Last updated
- 28 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolism and Pharmacokinetics Following Oral Administration of [14C]AZD1386 to Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00832169
- Acronym / sponsor ID
- D5090C00015
- Conditions
- Pain
- Keywords
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Study completion
- Feb 2009 (actual)
- First posted
- 30 Jan 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 aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1386 |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index of 18 - 30 and weight of 50 to 100 kilos.
- Healthy volunteer must have regular bowel movements (at least once daily)
Key exclusion criteria (3 listed)
- History of psychiatric or somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator.
- A family history of short QT syndrome or sudden cardiac death amongst first degree relatives.
- Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
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 |
|---|---|---|
| AZD13861 dose of oral solution | Drug | 1 |
Primary outcome
Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386
Time frame: Until >90% of predicted total radioactivity has been recovered
Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta
Time frame: Predose, + postdose 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144hPredose + postdose 1h, 4h, 8h, 24h for excreta from predose (baseline) + postdose from 0h continously until 144h
2 secondary outcomes
AZD1386 metabolites in plasma+excreta if feasable
Time frame: Predose, 1h, 4h, 8h 24h
Safety + tolerability of AZD1386
Time frame: Predose, 2h, 6h, 12h, 24h, 48h, 168h
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 28 Apr 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.
Raj Chetty, MD principal investigator
AstraZeneca R&D, CPU Alderley Park, UK
Lars Ståhle, MD study chair
AstraZeneca R&D, Södertälje, 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 AZD1386 in people with Pain, 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: finished, as of the sponsor's last update on 28 Apr 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 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?
Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386 (time frame: Until >90% of predicted total radioactivity has been recovered). 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 28 Apr 2009.