HealthyPhase 1NCT00688493
Effects of Single Oral Dose Dapagliflozin QT Study
A Phase 1 study testing Dapagliflozin and Moxifloxacin in people with Healthy, run by AstraZeneca at 1 site in United States.
Trial summary
The main purpose of this study is to examine the effect of dapagliflozin on electronic measures of heart beats in healthy males 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?
- Dapagliflozin and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Apr 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males age 18 to 45 years of age, who are not currently taking any medications
- Normal screening results including a physical examination, laboratory tests, heart rate, blood pressure, and ECG (electronic measure of the heart)
Who cannot join
- No personal or family history of significant heart problems
- No use of over the counter medications within 7 days of the study
- No use of prescription medicaiton within 1 month of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Four-period Crossover Study to Assess the Effects of Single Oral Dose Dapagliflozin Administration on QTc Interval Compared to Placebo, Using AVELOX™ (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers Age 18 to 45 Years
The main purpose of this study is to examine the effect of dapagliflozin on electronic measures of heart beats in healthy males
- Conditions
- Healthy
- Being tested
- Dapagliflozin, Moxifloxacin, Placebo to match moxifloxacin and dapagliflozin
- Keywords
- QT, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
3 x 50 mg tablets, single oral dose
DapagliflozinDrug
2 x 10 mg capsules, single oral dose
MoxifloxacinDrug
Also called Avelox™
Overencapsulated 400 mg capsule, single oral dose
Placebo to match moxifloxacin and dapagliflozinDrug
Overencapsulated 400 mg capsule, single oral dose
| Study group | Role | What they receive |
|---|---|---|
| 20 mg single dose of dapagliflozin | Experimental | 20 mg dapagliflozin Receives: Drug: Dapagliflozin; Drug: Moxifloxacin; Drug: Placebo to match moxifloxacin and dapagliflozin |
| 150 mg single dose of dapagliflozin2 | Experimental | 150 mg dapagliflozin Receives: Drug: Dapagliflozin; Drug: Moxifloxacin; Drug: Placebo to match moxifloxacin and dapagliflozin |
| 400 mg single dose of moxifloxacin | Active comparator | Moxifloxacin Receives: Drug: Dapagliflozin; Drug: Moxifloxacin; Drug: Placebo to match moxifloxacin and dapagliflozin |
| Placebo | Placebo comparator | Placebo Receives: Drug: Dapagliflozin; Drug: Moxifloxacin; Drug: Placebo to match moxifloxacin and dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electronic measures of heart beats
Measured: ECGs (electronic measures of the heart) are taken at scheduled times during the 3 days after receiving each dose of study medication
Secondary outcomes (2)
Blood levels of dapagliflozin following single 20 mg and 150 mg doses in healthy volunteers
Measured: At scheduled times during the 3 day periods following dosing during each of the 4 study periods
Safety and tolerability of dapagliflozin
Measured: Screening through completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startJul 2007
- Study completionApr 2008
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Glenn Carlson, MD, Study director, AstraZenecaRonald Goldwater, MD, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688493
- Sponsor's protocol ID
- D1690C00001
- Status last verified
- Mar 2012
- First submitted
- 30 May 2008
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Four-period Crossover Study to Assess the Effects of Single Oral Dose Dapagliflozin Administration on QTc Interval Compared to Placebo, Using AVELOX™ (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers Age 18 to 45 Years
- ClinicalTrials.gov ID
- NCT00688493
- Acronym / sponsor ID
- D1690C00001
- Conditions
- Healthy
- Keywords
- QT, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jul 2007
- Study completion
- Apr 2008 (actual)
- First posted
- 3 Jun 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 main purpose of this study is to examine the effect of dapagliflozin on electronic measures of heart beats in healthy males
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20 mg single dose of dapagliflozin | Experimental | Drug: Dapagliflozin, Drug: Moxifloxacin, Drug: Placebo to match moxifloxacin and dapagliflozin20 mg dapagliflozin |
| 150 mg single dose of dapagliflozin2 | Experimental | Drug: Dapagliflozin, Drug: Moxifloxacin, Drug: Placebo to match moxifloxacin and dapagliflozin150 mg dapagliflozin |
| 400 mg single dose of moxifloxacin | Active comparator | Drug: Dapagliflozin, Drug: Moxifloxacin, Drug: Placebo to match moxifloxacin and dapagliflozinMoxifloxacin |
| Placebo | Placebo comparator | Drug: Dapagliflozin, Drug: Moxifloxacin, Drug: Placebo to match moxifloxacin and dapagliflozinPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males age 18 to 45 years of age, who are not currently taking any medications
- Normal screening results including a physical examination, laboratory tests, heart rate, blood pressure, and ECG (electronic measure of the heart)
Key exclusion criteria (3 listed)
- No personal or family history of significant heart problems
- No use of over the counter medications within 7 days of the study
- No use of prescription medicaiton within 1 month of the study
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 |
|---|---|---|
| Dapagliflozin3 x 50 mg tablets, single oral dose | Drug | 150 mg single dose of dapagliflozin2, 20 mg single dose of dapagliflozin, 400 mg single dose of moxifloxacin, Placebo |
| Dapagliflozin2 x 10 mg capsules, single oral dose | Drug | 150 mg single dose of dapagliflozin2, 20 mg single dose of dapagliflozin, 400 mg single dose of moxifloxacin, Placebo |
| MoxifloxacinAlso: Avelox™Overencapsulated 400 mg capsule, single oral dose | Drug | 150 mg single dose of dapagliflozin2, 20 mg single dose of dapagliflozin, 400 mg single dose of moxifloxacin, Placebo |
| Placebo to match moxifloxacin and dapagliflozinOverencapsulated 400 mg capsule, single oral dose | Drug | 150 mg single dose of dapagliflozin2, 20 mg single dose of dapagliflozin, 400 mg single dose of moxifloxacin, Placebo |
Primary outcome
Electronic measures of heart beats
Time frame: ECGs (electronic measures of the heart) are taken at scheduled times during the 3 days after receiving each dose of study medication
2 secondary outcomes
Blood levels of dapagliflozin following single 20 mg and 150 mg doses in healthy volunteers
Time frame: At scheduled times during the 3 day periods following dosing during each of the 4 study periods
Safety and tolerability of dapagliflozin
Time frame: Screening through completion of the study
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 21 Mar 2012.
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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.
Glenn Carlson, MD study director
AstraZeneca
Ronald Goldwater, MD principal investigator
Parexel
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 Dapagliflozin and Moxifloxacin 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 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 21 Mar 2012. 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. 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?
Electronic measures of heart beats (time frame: ECGs (electronic measures of the heart) are taken at scheduled times during the 3 days after receiving each dose of study medication). 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 21 Mar 2012.