Diabetes Mellitus Type 2Phase 1MADNCT00841048
Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses
A Phase 1 study testing AZD4017 in people with Diabetes Mellitus Type 2, run by AstraZeneca at 1 site in Sweden.
Trial summary
The primary aim of this study is to investigate the safety and tolerability of AZD4017 when given as multiple oral ascending doses to healthy volunteers. This will be done by comparing the effect of AZD4017 to placebo. 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
- Diabetes Mellitus Type 2
- What is being tested?
- AZD4017
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2009to May 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
- BMI between 19 and 30 kg/m2
- Subjects must be willing to use barrier methods of contraception
Who cannot join
- History of any clinically significant disease
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Laboratory blood sample result showing elevated liver enzymes (ASAT, ALAT) and muscle enzymes (CK).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-blind, Placebo-controlled, Single Centre, Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses
The primary aim of this study is to investigate the safety and tolerability of AZD4017 when given as multiple oral ascending doses to healthy volunteers. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distribution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected and some measures of pharmacokinetics versus pharmacodynamics will be included. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- AZD4017, Placebo
- Keywords
- Safety and tolerability
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4017Drug
ascending multiple doses(start dose 75mg od), oral suspension
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD4017 in ascending doses (start dose 75mg od) Receives: Drug: AZD4017 |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables
Measured: The variables will be measured predose and then repeatedly during the study
Secondary outcomes (3)
Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal half-life, area under the plasma concentration-time curve and the apparent oral plasma clearance (CL/F)
Measured: Blood samples for determination of AZD4017 concentration will be taken predose and repeatedly during the study.
Laboratory screen to evaluate effect on metabolic variables
Measured: Blood samples will be taken pre-dose and repeatedly during the study
Pharmacodynamic measurements allowing to assess AZD4017 effect in different tissues
Measured: Baseline and repeatedly after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startFeb 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marianne Hartford, MD PhD, Principal investigator, AstraZeneca Clinical Pharmacolgy Unit Sahlgrenska University Hospital SE-413 45 Göteborg Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841048
- Sponsor's protocol ID
- D2060C00002
- Acronym
- MAD
- Status last verified
- Sep 2009
- First submitted
- 10 Feb 2009
- Last updated
- 30 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-blind, Placebo-controlled, Single Centre, Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses
- ClinicalTrials.gov ID
- NCT00841048
- Acronym / sponsor ID
- MAD / D2060C00002
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Safety and tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Study completion
- May 2009 (actual)
- First posted
- 11 Feb 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 primary aim of this study is to investigate the safety and tolerability of AZD4017 when given as multiple oral ascending doses to healthy volunteers. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distribution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected and some measures of pharmacokinetics versus pharmacodynamics will be included. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD4017AZD4017 in ascending doses (start dose 75mg od) |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
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
- BMI between 19 and 30 kg/m2
- Subjects must be willing to use barrier methods of contraception
Key exclusion criteria (4 listed)
- History of any clinically significant disease
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Laboratory blood sample result showing elevated liver enzymes (ASAT, ALAT) and muscle enzymes (CK).
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 |
|---|---|---|
| AZD4017ascending multiple doses(start dose 75mg od), oral suspension | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables
Time frame: The variables will be measured predose and then repeatedly during the study
3 secondary outcomes
Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal half-life, area under the plasma concentration-time curve and the apparent oral plasma clearance (CL/F)
Time frame: Blood samples for determination of AZD4017 concentration will be taken predose and repeatedly during the study.
Laboratory screen to evaluate effect on metabolic variables
Time frame: Blood samples will be taken pre-dose and repeatedly during the study
Pharmacodynamic measurements allowing to assess AZD4017 effect in different tissues
Time frame: Baseline and repeatedly after treatment
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 30 Sep 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.
Marianne Hartford, MD PhD principal investigator
AstraZeneca Clinical Pharmacolgy Unit Sahlgrenska University Hospital SE-413 45 Göteborg 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 AZD4017 in people with Diabetes Mellitus Type 2, run by AstraZeneca at 1 site in Sweden.
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 4 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 30 Sep 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 Sweden. 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?
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables (time frame: The variables will be measured predose and then repeatedly during the study). 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 30 Sep 2009.