TTR CardiomyopathyPhase 1NCT01655511
Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers
A Phase 1 study testing Tafamidis in people with TTR Cardiomyopathy, run by Pfizer at 1 site in Singapore.
Trial summary
This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- TTR Cardiomyopathy
- What is being tested?
- Tafamidis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2012to Sep 2012
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, males or females, 21 to 55 years old.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Condition affecting drug absorption. Blood pressure or ECG abnormalities. Recent treatment with an investigational, prescription, or non-prescription drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Crossover, Ascending Dose-Tolerance Study To Assess The Safety And Pharmacokinetics Of Tafamidis Doses Greater Than 120 Mg As Oral Solution In Healthy Volunteers
This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis
- Conditions
- TTR Cardiomyopathy
- Being tested
- Tafamidis
- Keywords
- Pharmacokinetic, pharmacodynamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafamidisDrug
240 mg, solution, single dose
TafamidisDrug
480 mg, solution, single dose
TafamidisDrug
TBD dose will be a single dose if < 720 mg or a loading dose followed by additional dose if > 720 mg.
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Experimental | 240 mg tafamidis arm Receives: Drug: Tafamidis |
| Period 2 | Experimental | 480 mg arm Receives: Drug: Tafamidis |
| Period 3 | Experimental | TBD dose Receives: Drug: Tafamidis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of orally administered tafamidis in healthy volunteers at escalating doses >120 mg. Safety assessments will include spontaneous reporting of adverse events, concomitant medications, physical examination,
Measured: Day 0 and Day 6
vital signs, ECGs, and clinical laboratory tests.
Measured: Day 0 and Day 6
Secondary outcomes (8)
Cmax - Maximum Observed Plasma Concentration (Cmax)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs
tmax - Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs
AUC0-24 - AreArea under the Concentration-Time Curve (AUC)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs
AUClast - Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs
AUCinf - Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs
t½ - Plasma Decay Half-Life (t1/2)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs
Transthyretin blood concentration in mg/dL
Measured: Days 0,1,2,3,4,5,6
Transthyretin stabilization (%)
Measured: Days 0,1,2,3,4,5,6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 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
- NCT01655511
- Sponsor's protocol ID
- B3461040
- Other IDs
- B3461040
- Status last verified
- Sep 2012
- First submitted
- 12 Jul 2012
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Crossover, Ascending Dose-Tolerance Study To Assess The Safety And Pharmacokinetics Of Tafamidis Doses Greater Than 120 Mg As Oral Solution In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01655511
- Acronym / sponsor ID
- B3461040
- Conditions
- TTR Cardiomyopathy
- Keywords
- Pharmacokinetic, pharmacodynamic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 2 Aug 2012 (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 in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Experimental | Drug: Tafamidis240 mg tafamidis arm |
| Period 2 | Experimental | Drug: Tafamidis480 mg arm |
| Period 3 | Experimental | Drug: TafamidisTBD dose |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy, males or females, 21 to 55 years old.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Condition affecting drug absorption. Blood pressure or ECG abnormalities. Recent treatment with an investigational, prescription, or non-prescription drug
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 |
|---|---|---|
| Tafamidis240 mg, solution, single dose | Drug | Period 1 |
| Tafamidis480 mg, solution, single dose | Drug | Period 2 |
| TafamidisTBD dose will be a single dose if < 720 mg or a loading dose followed by additional dose if > 720 mg. | Drug | Period 3 |
Primary outcome
To evaluate the safety and tolerability of orally administered tafamidis in healthy volunteers at escalating doses >120 mg. Safety assessments will include spontaneous reporting of adverse events, concomitant medications, physical examination,
Time frame: Day 0 and Day 6
vital signs, ECGs, and clinical laboratory tests.
Time frame: Day 0 and Day 6
8 secondary outcomes
Cmax - Maximum Observed Plasma Concentration (Cmax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs
tmax - Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs
AUC0-24 - AreArea under the Concentration-Time Curve (AUC)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs
AUClast - Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs
AUCinf - Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs
t½ - Plasma Decay Half-Life (t1/2)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs
Transthyretin blood concentration in mg/dL
Time frame: Days 0,1,2,3,4,5,6
Transthyretin stabilization (%)
Time frame: Days 0,1,2,3,4,5,6
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 27 Sep 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for TTR Cardiomyopathy
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To Evaluate the Long-term Safety and Tolerability of Acoramidis in Participants With Newly Diagnosed ATTR-CM (ACT-EARLY OLE)
Amyloidosis in Transthyretin (TTR), Amyloidosis, Familial
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Transthyretin (TTR) Amyloid Cardiomyopathy
RecruitingObservational study
Determining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study
Transthyretin (TTR) Amyloid Cardiomyopathy
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
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 Tafamidis in people with TTR Cardiomyopathy, run by Pfizer at 1 site in Singapore.
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 27 Sep 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 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?
To evaluate the safety and tolerability of orally administered tafamidis in healthy volunteers at escalating doses >120 mg. Safety assessments will include spontaneous reporting of adverse events, concomitant medications, physical examination, (time frame: Day 0 and Day 6). The study lists 2 primary outcomes in all. 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 27 Sep 2012; AzTrials last refreshed its copy on 8 Nov 2026.