HealthyPhase 1NCT00829127
AZD8075 Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses of AZD8075 in Healthy Male Volunteers
A Phase 1 study testing AZD8075 in people with Healthy, run by AstraZeneca.
Trial summary
The aims of the study are to evaluate the safety, tolerability and pharmacokinetics of AZD8075 in healthy male subjects at increasing doses when given for 14 days 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?
- AZD8075
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jan 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
- 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
- Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
- Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
- 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
About this study
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses of AZD8075 in Healthy Male Volunteers
The aims of the study are to evaluate the safety, tolerability and pharmacokinetics of AZD8075 in healthy male subjects at increasing doses when given for 14 days
- Conditions
- Healthy
- Being tested
- AZD8075, Placebo
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8075Drug
single dose, oral suspension, on Day 1. Repeated dosing will commence on Day 3 once daily for 14 days. The planned starting dose will be 35 mg with up to 2 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits or the exposure obtained so far in the SAD study.
PlaceboDrug
Oral suspension
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD8075 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
Measured: daily
Secondary outcomes (1)
characterise the multiple dose PK of AZD8075 and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK
Measured: daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2009 (estimated)
- Study completionJan 2009 (estimated)
Why it stopped: Due to termination of study D3801C00001, due to reports of turbid urine.
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
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eva Pettersson, Study director, AstraZeneca R&D, Lund, SwedenWolfgang Kühn, Principal investigator, Quintiles, Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829127
- Sponsor's protocol ID
- D3801C00004
- Other IDs
- EudraCt No.2008-006550-17
- Status last verified
- Aug 2011
- First submitted
- 20 Jan 2009
- Last updated
- 25 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses of AZD8075 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00829127
- Acronym / sponsor ID
- D3801C00004
- Conditions
- Healthy
- Keywords
- volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to termination of study D3801C00001, due to reports of turbid urine.
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 26 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 aims of the study are to evaluate the safety, tolerability and pharmacokinetics of AZD8075 in healthy male subjects at increasing doses when given for 14 days
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 |
|---|---|---|
| 1 | Experimental | Drug: AZD8075 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of signed, written and dated informed consent prior to any study specific procedures
- 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)
- Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
- Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
- 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 |
|---|---|---|
| AZD8075single dose, oral suspension, on Day 1. Repeated dosing will commence on Day 3 once daily for 14 days. The planned starting dose will be 35 mg with up to 2 dose escalations not exceeding AstraZeneca pre-defined upper exposure limits or the exposure obtained so far in the SAD study. | Drug | 1 |
| PlaceboOral suspension | Drug | 2 |
Primary outcome
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
Time frame: daily
1 secondary outcome
characterise the multiple dose PK of AZD8075 and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK
Time frame: daily
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2011.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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
Wolfgang Kühn principal investigator
Quintiles, Uppsala, Sweden
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD8075 in people with Healthy, run by AstraZeneca.
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: withdrawn, as of the sponsor's last update on 25 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) (time frame: daily). 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 25 Aug 2011.