HealthyPhase 1NCT00984477
Study to Investigate the Activity of AZD5122 When Given as a Single Dose to Healthy Male Subjects
A Phase 1 study testing AZD5122 in people with Healthy, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of the study is to determine how quickly AZD5122 is absorbed into and cleared by the body when given to healthy, non smoking males at different dose levels. This is a 2 part study, in Part B a single group of subjects will be given both an oral dose and intravenous microdose of AZD5122 at a specialist… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD5122
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated, written informed consent.
- Normal physical examination, laboratory values, blood pressure and pulse
- Healthy male caucasian subjects
Who cannot join
- Subjects must not have any history of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body.
- Subjects must not have abnormal blood or urine tests for hsCRP, circulating neutrophils, haematocrit, haemoglobin or renal function
- Subjects must not have crystals or more than a trace of blood in their urine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Exploratory Study to Assess the Pharmacokinetics of Single Oral Doses and a Single Intravenous Radiolabelled Microtracer Dose of AZD5122 in Healthy Male Subjects
The purpose of the study is to determine how quickly AZD5122 is absorbed into and cleared by the body when given to healthy, non smoking males at different dose levels. This is a 2 part study, in Part B a single group of subjects will be given both an oral dose and intravenous microdose of AZD5122 at a specialist unit. For part B there is no placebo treatment given.
- Conditions
- Healthy
- Being tested
- AZD5122, Placebo
- Keywords
- Healthy volunteer, healthy subjects, AZD5122, single oral dose, phase 1, Healthy volunteer phase 1 study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5122Drug
A single dose of oral suspension
PlaceboDrug
A single dose of oral suspension
AZD5122Drug
A single intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD5122 oral suspension (part A and B) Receives: Drug: AZD5122 |
| 2 | Placebo comparator | Placebo oral suspension (part A) Receives: Drug: Placebo |
| 3 | Experimental | AZD5122 oral and IV infusion (part B) Receives: Drug: AZD5122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile: concentration of AZD5122 in blood
Measured: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
Secondary outcomes (3)
Pharmacokinetic profile: concentration of AZD5122 in urine
Measured: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
Measurement of the effect of AZD5122 on circulating neutrophils
Measured: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
Pharmacodynamic profile: assessment of various pharmacodynamic measures
Measured: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startSep 2009
- Study completionNov 2009
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew Sparrow, BSc, BMedSci, BM,BS, Principal investigator, AstraZeneca Clinical Pharmacology Unit, Queens Medical Centre, Nottingham NG7 2UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984477
- Sponsor's protocol ID
- D2650C00006
- Status last verified
- Dec 2009
- First submitted
- 24 Sep 2009
- Last updated
- 4 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Exploratory Study to Assess the Pharmacokinetics of Single Oral Doses and a Single Intravenous Radiolabelled Microtracer Dose of AZD5122 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00984477
- Acronym / sponsor ID
- D2650C00006
- Conditions
- Healthy
- Keywords
- Healthy volunteer, healthy subjects, AZD5122, single oral dose, phase 1, Healthy volunteer phase 1 study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Study completion
- Nov 2009 (actual)
- First posted
- 25 Sep 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 the study is to determine how quickly AZD5122 is absorbed into and cleared by the body when given to healthy, non smoking males at different dose levels. This is a 2 part study, in Part B a single group of subjects will be given both an oral dose and intravenous microdose of AZD5122 at a specialist unit. For part B there is no placebo treatment given.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD5122AZD5122 oral suspension (part A and B) |
| 2 | Placebo comparator | Drug: PlaceboPlacebo oral suspension (part A) |
| 3 | Experimental | Drug: AZD5122AZD5122 oral and IV infusion (part B) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of signed and dated, written informed consent.
- Normal physical examination, laboratory values, blood pressure and pulse
- Healthy male caucasian subjects
Key exclusion criteria (3 listed)
- Subjects must not have any history of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body.
- Subjects must not have abnormal blood or urine tests for hsCRP, circulating neutrophils, haematocrit, haemoglobin or renal function
- Subjects must not have crystals or more than a trace of blood in their urine
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 |
|---|---|---|
| AZD5122A single dose of oral suspension | Drug | 1, 3 |
| PlaceboA single dose of oral suspension | Drug | 2 |
| AZD5122A single intravenous infusion | Drug | 3 |
Primary outcome
Pharmacokinetic profile: concentration of AZD5122 in blood
Time frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
3 secondary outcomes
Pharmacokinetic profile: concentration of AZD5122 in urine
Time frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
Measurement of the effect of AZD5122 on circulating neutrophils
Time frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
Pharmacodynamic profile: assessment of various pharmacodynamic measures
Time frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-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 4 Dec 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.
Andrew Sparrow, BSc, BMedSci, BM,BS principal investigator
AstraZeneca Clinical Pharmacology Unit, Queens Medical Centre, Nottingham NG7 2UH
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 AZD5122 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 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 4 Dec 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. Some participants in this study may receive a placebo. 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?
Pharmacokinetic profile: concentration of AZD5122 in blood (time frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.). 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 4 Dec 2009.