HealthyPhase 1NCT00799331
Exploratory Study to Assess the Pharmacokinetics of AZD5985
A Phase 1 study testing AZD5985 in people with Healthy, run by AstraZeneca at 1 site in Germany.
Trial summary
The aim of this exploratory study is to assess the pharmacokinetics of increasing oral doses of AZD5985 in healthy male volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD5985
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed, written and dated informed consent prior to any study specific procedures.
- Healthy male subjects aged 18 to 45 years (inclusive).
- Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
- Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.
Who cannot join
- History or presence of any clinically significant disease or disorder in the opinion of the investigator.
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
- Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Phase I, Single Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study to Assess the Pharmacokinetics of Increasing Oral Doses of AZD5985 in Healthy Male Volunteers
The aim of this exploratory study is to assess the pharmacokinetics of increasing oral doses of AZD5985 in healthy male volunteers
- Conditions
- Healthy
- Being tested
- AZD5985, placebo
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5985Drug
Oral suspension. Single oral doses of AZD5985 starting with 4 mg and subsequently with up to 3 dose escalations will be administered not exceeding AstraZeneca pre-defined upper exposure limits.
placeboDrug
Oral suspension.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | AZD5985 Receives: Drug: AZD5985 |
| B | Experimental | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
It is the objective of this exploratory study to assess pharmacokinetics of AZD5985 following administration of single increasing doses. The primary variable is plasma concentration of AZD5985.
Measured: Frequent sampling occasions during study days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 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 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, Care provider, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eva Pettersson, Study director, AstraZeneca R&D, Lund, SwedenMaura Fallon, Principal investigator, Parexel, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799331
- Sponsor's protocol ID
- D2300C00001
- Other IDs
- EudraCt No. 2008-005121-11
- Status last verified
- Jun 2009
- First submitted
- 21 Nov 2008
- Last updated
- 9 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Phase I, Single Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study to Assess the Pharmacokinetics of Increasing Oral Doses of AZD5985 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00799331
- Acronym / sponsor ID
- D2300C00001
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 27 Nov 2008 (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 exploratory study is to assess the pharmacokinetics of increasing oral doses of AZD5985 in healthy male volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AZD5985AZD5985 |
| B | Experimental | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Provision of signed, written and dated informed consent prior to any study specific procedures.
- Healthy male subjects aged 18 to 45 years (inclusive).
- Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
- Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.
Key exclusion criteria (3 listed)
- History or presence of any clinically significant disease or disorder in the opinion of the investigator.
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
- Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2
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 |
|---|---|---|
| AZD5985Oral suspension. Single oral doses of AZD5985 starting with 4 mg and subsequently with up to 3 dose escalations will be administered not exceeding AstraZeneca pre-defined upper exposure limits. | Drug | A |
| placeboOral suspension. | Drug | B |
Primary outcome
It is the objective of this exploratory study to assess pharmacokinetics of AZD5985 following administration of single increasing doses. The primary variable is plasma concentration of AZD5985.
Time frame: Frequent sampling occasions during study days
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 9 Jun 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.
Eva Pettersson study director
AstraZeneca R&D, Lund, Sweden
Maura Fallon principal investigator
Parexel, Berlin, Germany
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 AZD5985 in people with Healthy, run by AstraZeneca at 1 site in Germany.
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 9 Jun 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 Germany. 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?
It is the objective of this exploratory study to assess pharmacokinetics of AZD5985 following administration of single increasing doses. The primary variable is plasma concentration of AZD5985. (time frame: Frequent sampling occasions during study days). 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 9 Jun 2009.