TTR CardiomyopathyPhase 1NCT01775761
A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc)
A Phase 1 study testing Period 1, Period 2 and Period 3 in people with TTR Cardiomyopathy, run by Pfizer at 3 sites in 3 countries.
Trial summary
The purpose of this study is to investigate the effects of tafamidis on the intervals of the electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- TTR Cardiomyopathy
- What is being tested?
- Period 1, Period 2 and Period 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2013to Apr 2013
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, nonsmoking, male and/or female subjects of non-childbearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
- Total body weight >50 kg (110 lbs).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- An ALT or AST measurement >2 times the ULN.
- 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening.
- Subjects at increased risk if dosed with moxifloxacin, according to the product label for moxifloxacin.
- History of risk factors of QT prolongation or torsades de pointes, congenital deafness and family history of sudden death.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Randomized, Placebo- And Positive-Controlled Cross-Over Study To Evaluate The Effect Of Tafamidis On The QTC Interval In Healthy Volunteers
The purpose of this study is to investigate the effects of tafamidis on the intervals of the electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.
- Conditions
- TTR Cardiomyopathy
- Being tested
- Period 1, Period 2, Period 3
- Keywords
- Thorough QTc evaluation of tafamidis compared to the effects of moxifloxacin and placebo in healthy volunteers.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Period 1Drug
Also called tafamidis (Vyndaqel)
A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
Period 2Drug
Also called moxifloxacin
A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
Period 3Drug
A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
| Study group | Role | What they receive |
|---|---|---|
| Period 1: 960 mg tafamidis (Vyndaqel) | Experimental | Not described Receives: Drug: Period 1 |
| Period 2: 400 mg moxifloxacin | Experimental | 400 mg moxifloxacin Receives: Drug: Period 2 |
| Period 3: Placebo | Experimental | Not described Receives: Drug: Period 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc interval using Fridericia's correction method (QTcF) of tafamidis and placebo (baseline-adjusted) at each post-dose time
Measured: SCRN, -1, -0.5, 0, 1, 1.5, 2, 3, 4, 6, 12, 24 hrs
Secondary outcomes (4)
QTcF of moxifloxacin and placebo at historical moxifloxacin median Tmax of 3 hours.
Measured: Scrn, -1, -0.5, 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
Tmax
Measured: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
Cmax
Measured: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
AUC0-24
Measured: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2013
- Study completionApr 2013
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 TTR CardiomyopathyStudies of the same condition, open and under way.
- More trials run by PfizerThe 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, Care provider
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775761
- Sponsor's protocol ID
- B3461031
- Status last verified
- May 2013
- First submitted
- 15 Jan 2013
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Klamerus KJ, Watsky E, Moller R, Wang R, Riley S. The effect of tafamidis on the QTc interval in healthy subjects. Br J Clin Pharmacol. 2015 Jun;79(6):918-25. doi: 10.1111/bcp.12561.
PubMed 25546001
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo- And Positive-Controlled Cross-Over Study To Evaluate The Effect Of Tafamidis On The QTC Interval In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01775761
- Acronym / sponsor ID
- B3461031
- Conditions
- TTR Cardiomyopathy
- Keywords
- Thorough QTc evaluation of tafamidis compared to the effects of moxifloxacin and placebo in healthy volunteers.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 25 Jan 2013 (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 investigate the effects of tafamidis on the intervals of the electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Period 1: 960 mg tafamidis (Vyndaqel) | Experimental | Drug: Period 1 |
| Period 2: 400 mg moxifloxacin | Experimental | Drug: Period 2400 mg moxifloxacin |
| Period 3: Placebo | Experimental | Drug: Period 3 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, nonsmoking, male and/or female subjects of non-childbearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
- Total body weight >50 kg (110 lbs).
Key exclusion criteria (5 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- An ALT or AST measurement >2 times the ULN.
- 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening.
- Subjects at increased risk if dosed with moxifloxacin, according to the product label for moxifloxacin.
- History of risk factors of QT prolongation or torsades de pointes, congenital deafness and family history of sudden death.
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 |
|---|---|---|
| Period 1Also: tafamidis (Vyndaqel)A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval. | Drug | Period 1: 960 mg tafamidis (Vyndaqel) |
| Period 2Also: moxifloxacinA comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval. | Drug | Period 2: 400 mg moxifloxacin |
| Period 3A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval. | Drug | Period 3: Placebo |
Primary outcome
QTc interval using Fridericia's correction method (QTcF) of tafamidis and placebo (baseline-adjusted) at each post-dose time
Time frame: SCRN, -1, -0.5, 0, 1, 1.5, 2, 3, 4, 6, 12, 24 hrs
4 secondary outcomes
QTcF of moxifloxacin and placebo at historical moxifloxacin median Tmax of 3 hours.
Time frame: Scrn, -1, -0.5, 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
Tmax
Time frame: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
Cmax
Time frame: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
AUC0-24
Time frame: 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs
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 May 2013.
- Derived from this study: PubMed 25546001Klamerus KJ, Watsky E, Moller R, Wang R, Riley S. The effect of tafamidis on the QTc interval in healthy subjects. Br J Clin Pharmacol. 2015 Jun;79(6):918-25. doi: 10.1111/bcp.12561.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Period 1, Period 2 and Period 3 in people with TTR Cardiomyopathy, run by Pfizer at 3 sites in 3 countries.
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 5 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 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Belgium, Singapore. 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?
QTc interval using Fridericia's correction method (QTcF) of tafamidis and placebo (baseline-adjusted) at each post-dose time (time frame: SCRN, -1, -0.5, 0, 1, 1.5, 2, 3, 4, 6, 12, 24 hrs). 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 NCT01775761, 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 21 May 2013.