HealthyPhase 1NCT00726427
A Study to Evaluate Safety and Tolerability After Oral Dosing of AZD1656 in Healthy Volunteers
A Phase 1 study testing AZD1656 in people with Healthy, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in healthy male subjects Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD1656
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Sep 2008
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of informed consent
- Clinically normal physical findings and laboratory values as judged by the investigator including negative test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to hepatitis C virus.
Who cannot join
- Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the Investigational Product
- History of psychiatric or somatic disease/condition that may interfere with the objectives of the study, as judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD1656 in Healthy Male Subjects
The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in healthy male subjects
- Conditions
- Healthy
- Being tested
- AZD1656
- Keywords
- pharmacokinetics, pharmacodynamics, AZD1656, safety, tolerability, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1656Drug
Dose escalation to achieve maximum tolerated dose
AZD1656Drug
Oral single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 8 increasing oral single doses given to 8 groups (3 on active and 1 on placebo in each group) Receives: Drug: AZD1656 |
| 2 | Experimental | 2 oral doses of AZD1656 given to 2 groups together with food Receives: Drug: AZD1656 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables (AE's, BP, pulse, lab variables, and ECG)
Measured: Safety variables taken repeatedly during 24 hours on study day sessions
Secondary outcomes (2)
Pharmacokinetic variables
Measured: Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions
Pharmacodynamic variables
Measured: Blood samples taken repeatedly during 24 hours on study day sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Klas Malmberg, MD, PhD, Study director, AstraZeneca R&D MölndalSylvan Hurewitz, MD, Principal investigator, AstraZeneca CPU, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726427
- Sponsor's protocol ID
- D1020C00001
- Status last verified
- Dec 2010
- First submitted
- 29 Jul 2008
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Ericsson H, Roshammar D, Wollbratt M, Heijer M, Persson M, Ueda S, Leonsson-Zachrisson M, Norjavaara E. Tolerability, pharmacokinetics, and pharmacodynamics of the glucokinase activator AZD1656, after single ascending doses in healthy subjects during euglycemic clamp. Int J Clin Pharmacol Ther. 2012 Nov;50(11):765-77. doi: 10.5414/CP201747.
PubMed 22943931
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD1656 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00726427
- Acronym / sponsor ID
- D1020C00001
- Conditions
- Healthy
- Keywords
- pharmacokinetics, pharmacodynamics, AZD1656, safety, tolerability, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 1 Aug 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 purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD16568 increasing oral single doses given to 8 groups (3 on active and 1 on placebo in each group) |
| 2 | Experimental | Drug: AZD16562 oral doses of AZD1656 given to 2 groups together with food |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Provision of informed consent
- Clinically normal physical findings and laboratory values as judged by the investigator including negative test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to hepatitis C virus.
Key exclusion criteria (2 listed)
- Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the Investigational Product
- History of psychiatric or somatic disease/condition that may interfere with the objectives of the study, as judged by the investigator
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 |
|---|---|---|
| AZD1656Dose escalation to achieve maximum tolerated dose | Drug | 1 |
| AZD1656Oral single dose | Drug | 2 |
Primary outcome
Safety variables (AE's, BP, pulse, lab variables, and ECG)
Time frame: Safety variables taken repeatedly during 24 hours on study day sessions
2 secondary outcomes
Pharmacokinetic variables
Time frame: Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions
Pharmacodynamic variables
Time frame: Blood samples taken repeatedly during 24 hours on study day sessions
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 3 Dec 2010.
- Derived from this study: PubMed 22943931Ericsson H, Roshammar D, Wollbratt M, Heijer M, Persson M, Ueda S, Leonsson-Zachrisson M, Norjavaara E. Tolerability, pharmacokinetics, and pharmacodynamics of the glucokinase activator AZD1656, after single ascending doses in healthy subjects during euglycemic clamp. Int J Clin Pharmacol Ther. 2012 Nov;50(11):765-77. doi: 10.5414/CP201747.
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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.
Klas Malmberg, MD, PhD study director
AstraZeneca R&D Mölndal
Sylvan Hurewitz, MD principal investigator
AstraZeneca CPU, Philadelphia, PA
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 AZD1656 in people with Healthy, run by AstraZeneca at 1 site in United States.
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 2 inclusion and 2 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 3 Dec 2010. 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 States. 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?
Safety variables (AE's, BP, pulse, lab variables, and ECG) (time frame: Safety variables taken repeatedly during 24 hours on study day sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00726427, which also lists 1 linked publication.
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 3 Dec 2010.