NeuroscienceADMENCT01223014
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] AZD2423 in Volunteers
An observational study of Neuroscience, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C]AZD2423 in healthy male volunteers aged 50 to 65 years (inclusive).The purpose of this study is to investigate how and how quickly AZD 2423 or its… 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
- Neuroscience
- What is being tested?
- AZD2423
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to Dec 2010
- Phase
- Observational
- 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
Study population: primary care clinic/community sample
Who may be able to join
- Have a body mass index (BMI) of ≥18 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)
- Provision of signed and dated, written informed consent prior to any study specific procedures
Who cannot join
- Healthy volunteers exposed to radiation levels above background (eg, through X ray examination) of >5 mSv in the last year, >10 mSv over 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 intake of more than 15 units of alcohol a week. (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Single Dose, Phase I Study to Evaluate the Excretion of Radioactivity, the Metabolic Profile, Pharmacokinetics, Safety and Tolerability Following Single Oral Administration of [14C]AZD2423 to Healthy Male Volunteers
Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C]AZD2423 in healthy male volunteers aged 50 to 65 years (inclusive).The purpose of this study is to investigate how and how quickly AZD 2423 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.
- Conditions
- Neuroscience
- Being tested
- AZD2423
- Keywords
- Radioactive, ADME, Neuropathic pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2423Drug
AZD2423
| Study group | Role | What they receive |
|---|---|---|
| 1 | Single cohort of 6 subjects Receives: Drug: AZD2423 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of radioactive dose recovered in urine and faeces and total percentage
Measured: During residential period on Day 1
Percentage of radioactive dose recovered in urine and faeces and total percentage
Measured: During residential period on Day 2
Percentage of radioactive dose recovered in urine and faeces and total percentage
Measured: During residential period on Day 3
Percentage of radioactive dose recovered in urine and faeces and total percentage
Measured: During residential period on Day 4
Percentage of radioactive dose recovered in urine and faeces and total percentage
Measured: During residential period on Day 5
Percentage of radioactive dose recovered in urine and faeces and total percentage
Measured: During residential period on Day 6
Percentage of radioactive dose recovered in urine and faeces and total percentage
Measured: During residential period on Day 7
Percentage of radioactive dose recovered in urine and faeces and total percentage
Measured: During residential period on Day 8
Concentration of total radioactivity in blood and plasma
Measured: During residential period on Day 1
Concentration of total radioactivity in blood and plasma
Measured: During residential period on Day 2
Concentration of total radioactivity in blood and plasma
Measured: During residential period on Day 3
Concentration of total radioactivity in blood and plasma
Measured: During residential period on Day 4
Concentration of total radioactivity in blood and plasma
Measured: During residential period on Day 5
Concentration of total radioactivity in blood and plasma
Measured: During residential period on Day 6
Concentration of total radioactivity in blood and plasma
Measured: During residential period on Day 7
Concentration of total radioactivity in blood and plasma
Measured: During residential period on Day 8
Secondary outcomes (9)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing adverse events
Measured: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing concomitant medications
Measured: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing clinical chemistry
Measured: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing haematology
Measured: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing urinalysis
Measured: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing vital signs
Measured: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing body weight
Measured: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing electrocardiogram
Measured: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by physical examination
Measured: Range of Day -1 until follow up visit (Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroscienceStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Biljana Lilja, Study director, AstraZenecaMarianne Kasti, Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223014
- Sponsor's protocol ID
- D2600C00008
- Acronym
- ADME
- Status last verified
- Feb 2011
- First submitted
- 15 Oct 2010
- Last updated
- 8 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Dose, Phase I Study to Evaluate the Excretion of Radioactivity, the Metabolic Profile, Pharmacokinetics, Safety and Tolerability Following Single Oral Administration of [14C]AZD2423 to Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01223014
- Acronym / sponsor ID
- ADME / D2600C00008
- Conditions
- Neuroscience
- Keywords
- Radioactive, ADME, Neuropathic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Oct 2010 (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.
Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C]AZD2423 in healthy male volunteers aged 50 to 65 years (inclusive).The purpose of this study is to investigate how and how quickly AZD 2423 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: AZD2423Single cohort of 6 subjects |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic/community sample
Key inclusion criteria (3 listed)
- Have a body mass index (BMI) of ≥18 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)
- Provision of signed and dated, written informed consent prior to any study specific procedures
Key exclusion criteria (3 listed)
- Healthy volunteers exposed to radiation levels above background (eg, through X ray examination) of >5 mSv in the last year, >10 mSv over 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 intake of more than 15 units of alcohol a week. (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer)
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 |
|---|---|---|
| AZD2423AZD2423 | Drug | 1 |
Primary outcome
Percentage of radioactive dose recovered in urine and faeces and total percentage
Time frame: During residential period on Day 1
Percentage of radioactive dose recovered in urine and faeces and total percentage
Time frame: During residential period on Day 2
Percentage of radioactive dose recovered in urine and faeces and total percentage
Time frame: During residential period on Day 3
Percentage of radioactive dose recovered in urine and faeces and total percentage
Time frame: During residential period on Day 4
Percentage of radioactive dose recovered in urine and faeces and total percentage
Time frame: During residential period on Day 5
Percentage of radioactive dose recovered in urine and faeces and total percentage
Time frame: During residential period on Day 6
Percentage of radioactive dose recovered in urine and faeces and total percentage
Time frame: During residential period on Day 7
Percentage of radioactive dose recovered in urine and faeces and total percentage
Time frame: During residential period on Day 8
Concentration of total radioactivity in blood and plasma
Time frame: During residential period on Day 1
Concentration of total radioactivity in blood and plasma
Time frame: During residential period on Day 2
Concentration of total radioactivity in blood and plasma
Time frame: During residential period on Day 3
Concentration of total radioactivity in blood and plasma
Time frame: During residential period on Day 4
Concentration of total radioactivity in blood and plasma
Time frame: During residential period on Day 5
Concentration of total radioactivity in blood and plasma
Time frame: During residential period on Day 6
Concentration of total radioactivity in blood and plasma
Time frame: During residential period on Day 7
Concentration of total radioactivity in blood and plasma
Time frame: During residential period on Day 8
9 secondary outcomes
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing adverse events
Time frame: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing concomitant medications
Time frame: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing clinical chemistry
Time frame: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing haematology
Time frame: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing urinalysis
Time frame: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing vital signs
Time frame: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing body weight
Time frame: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing electrocardiogram
Time frame: Range of Day -1 until follow up visit (Visit 3)
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by physical examination
Time frame: Range of Day -1 until follow up visit (Visit 3)
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 8 Feb 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.
Biljana Lilja study director
AstraZeneca
Marianne Kasti principal investigator
Quintiles, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroscience, 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 3 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 8 Feb 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.
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?
Percentage of radioactive dose recovered in urine and faeces and total percentage (time frame: During residential period on Day 1). The study lists 16 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 8 Feb 2011.