Fibrillation, AtrialPhase 1NCT00437242
Odiparcil QT Definitive Study
A Phase 1 study testing Odiparcil in people with Fibrillation, Atrial and Atrial Fibrillation, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study is being completed to demonstrate the lack of effect of repeat dosing with Odiparcil on the QTc interval. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibrillation, Atrial, Atrial Fibrillation
- What is being tested?
- Odiparcil
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to not given
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Cardiac abnormalities
- Hepatic or renal insufficiency
- Anti-coagulant medications
- Bleeding history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Effect of Repeat Oral Doses of Odiparcil on Cardiac Conduction as Assessed by 12-lead Electrocardiogram Compared to Placebo and a Single Oral Dose of Moxifloxacin.
This study is being completed to demonstrate the lack of effect of repeat dosing with Odiparcil on the QTc interval.
- Conditions
- Fibrillation, Atrial, Atrial Fibrillation
- Being tested
- Odiparcil
- Keywords
- interval,, atrial fibrillation, QT,, odiparcil,
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OdiparcilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
demonstrate lack of effect of repeat dose on QT interval with ECG measured on Days -1, 5 and 6 at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours
Secondary outcomes (1)
Pharmacokinetics, CMAX, AUC, TMAX, PK samples taken at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours on days 5 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrillation, AtrialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Crossover
- Masking
- Double blind
- Enrolment
- 54 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437242
- Sponsor's protocol ID
- ITI103221
- Status last verified
- Mar 2011
- First submitted
- 16 Feb 2007
- Last updated
- 4 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of Repeat Oral Doses of Odiparcil on Cardiac Conduction as Assessed by 12-lead Electrocardiogram Compared to Placebo and a Single Oral Dose of Moxifloxacin.
- ClinicalTrials.gov ID
- NCT00437242
- Acronym / sponsor ID
- ITI103221
- Conditions
- Fibrillation, Atrial, Atrial Fibrillation
- Keywords
- interval,, atrial fibrillation, QT,, odiparcil,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 54 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- First posted
- 19 Feb 2007 (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.
This study is being completed to demonstrate the lack of effect of repeat dosing with Odiparcil on the QTc interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (4 listed)
- Cardiac abnormalities
- Hepatic or renal insufficiency
- Anti-coagulant medications
- Bleeding history
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 |
|---|---|---|
| Odiparcil | Drug | – |
Primary outcome
demonstrate lack of effect of repeat dose on QT interval with ECG measured on Days -1, 5 and 6 at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours
1 secondary outcome
Pharmacokinetics, CMAX, AUC, TMAX, PK samples taken at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours on days 5 and 6
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Odiparcil in people with Fibrillation, Atrial and Atrial Fibrillation, run by GlaxoSmithKline 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 1 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: stopped early, as of the sponsor's last update on 4 Jun 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. 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 stopped early. Results are not available in the source record.
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?
demonstrate lack of effect of repeat dose on QT interval with ECG measured on Days -1, 5 and 6 at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours. 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 4 Jun 2012; AzTrials last refreshed its copy on 28 Oct 2026.