HealthyPhase 1TQTNCT00686179
Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days
A Phase 1 study testing AZD3480 and Moxifloxacin in people with Healthy, run by AstraZeneca.
Trial summary
The purpose of this study is to evaluate the effects on cardiac repolarisation of supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using moxifloxacin as positive control. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD3480 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Aug 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participation in a previous study for genotyping for identification to be extensive or poor metaboliser (CYP2D6 enzyme)
- Physically and mentally healthy male volunteers
Who cannot join
- History of clinically significant diseases or illness.
- Participation in another study the last 3 months
- Prescribed or non-prescribed medications from 3 weeks prior to first treatment day until follow-up except for paracetamol (max 1.5 g per day.)
About this study
Official title: A Double-Blind, Randomised, Multicentre, Placebo-Controlled, 4-Ways Crossover Study to Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days, Using Moxifloxacin as a Positive Control, in Healthy Male Volunteers, CYP2D6 Extensive and Poor Metabolisers.
The purpose of this study is to evaluate the effects on cardiac repolarisation of supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using moxifloxacin as positive control.
- Conditions
- Healthy
- Being tested
- AZD3480, Moxifloxacin, PLACEBO
- Keywords
- TQT, ECG, QT, QTc, AZD3480, ECG(QTc effects)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3480Drug
Also called TC-1734-226
Capsule, oral, single dose, 6 days
MoxifloxacinDrug
Capsule(encapsulated), oral, single dose
PLACEBODrug
Capsule, oral, single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Escalating doses of AZD3480 during 6 days Receives: Drug: AZD3480 |
| 2 | Experimental | Repeated doses of AZD3480 during 6 days Receives: Drug: AZD3480 |
| 3 | Placebo comparator | Placebo during 6 days Receives: Drug: PLACEBO |
| 4 | Active comparator | Placebo during 5 days, active day 6 Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTcX interval (supratherapeutic doses in comparison to placebo).Subject-specific correction of QT, QTcF and QTcB (supportive outcome variables).Bazett QTcB=QT*RR-1/2Fridericia QTcF=QT'RR-1/3
Measured: 11 dECG measurements x 4 (4-way crossover)
Secondary outcomes (3)
QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals
Measured: 11 dECG measurements x 4 (4-way crossover)
Plasma concentration (AUC, Cmax, tmax etc)
Measured: 11 PK-measurements x 4 (4-way crossover)
Registration of AEs, blood pressure, ECG, clinical laboratory tests
Measured: From enrolment to follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startJan 2008
- Primary completionAug 2008
- Study completionAug 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hans-Göran Hårdemark, Study director, Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686179
- Sponsor's protocol ID
- D3690C00004
- Other IDs
- EUdract NO 2007-004859-11
- Acronym
- TQT
- Status last verified
- Sep 2008
- First submitted
- 27 May 2008
- Last updated
- 25 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomised, Multicentre, Placebo-Controlled, 4-Ways Crossover Study to Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days, Using Moxifloxacin as a Positive Control, in Healthy Male Volunteers, CYP2D6 Extensive and Poor Metabolisers.
- ClinicalTrials.gov ID
- NCT00686179
- Acronym / sponsor ID
- TQT / D3690C00004
- Conditions
- Healthy
- Keywords
- TQT, ECG, QT, QTc, AZD3480, ECG(QTc effects)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 29 May 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 evaluate the effects on cardiac repolarisation of supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using moxifloxacin as positive control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD3480Escalating doses of AZD3480 during 6 days |
| 2 | Experimental | Drug: AZD3480Repeated doses of AZD3480 during 6 days |
| 3 | Placebo comparator | Drug: PLACEBOPlacebo during 6 days |
| 4 | Active comparator | Drug: MoxifloxacinPlacebo during 5 days, active day 6 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participation in a previous study for genotyping for identification to be extensive or poor metaboliser (CYP2D6 enzyme)
- Physically and mentally healthy male volunteers
Key exclusion criteria (3 listed)
- History of clinically significant diseases or illness.
- Participation in another study the last 3 months
- Prescribed or non-prescribed medications from 3 weeks prior to first treatment day until follow-up except for paracetamol (max 1.5 g per day.)
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 |
|---|---|---|
| AZD3480Also: TC-1734-226Capsule, oral, single dose, 6 days | Drug | 1, 2 |
| MoxifloxacinCapsule(encapsulated), oral, single dose | Drug | 4 |
| PLACEBOCapsule, oral, single dose | Drug | 3 |
Primary outcome
QTcX interval (supratherapeutic doses in comparison to placebo).Subject-specific correction of QT, QTcF and QTcB (supportive outcome variables).Bazett QTcB=QT*RR-1/2Fridericia QTcF=QT'RR-1/3
Time frame: 11 dECG measurements x 4 (4-way crossover)
3 secondary outcomes
QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals
Time frame: 11 dECG measurements x 4 (4-way crossover)
Plasma concentration (AUC, Cmax, tmax etc)
Time frame: 11 PK-measurements x 4 (4-way crossover)
Registration of AEs, blood pressure, ECG, clinical laboratory tests
Time frame: From enrolment to follow-up
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 25 Sep 2008.
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.
Hans-Göran Hårdemark study director
Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD3480 and Moxifloxacin 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 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 25 Sep 2008. 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 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?
QTcX interval (supratherapeutic doses in comparison to placebo).Subject-specific correction of QT, QTcF and QTcB (supportive outcome variables).Bazett QTcB=QT*RR-1/2Fridericia QTcF=QT'RR-1/3 (time frame: 11 dECG measurements x 4 (4-way crossover)). 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 Sep 2008.