HealthyPhase 1NCT02534740
A Study Comparing Amounts of Tafamidis In The Blood With Or Without Food
A Phase 1 study testing tafamidis in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- tafamidis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2015to Dec 2015
- 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 males or females of non-child bearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).
Who cannot join
- Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
- Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
- Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Randomized, Single Dose Study To Estimate The Relative Bioavailability And Food Effect Of PF-06291826 (Tafamidis) Following Administration Of New Soft Gelatin Capsule Oral Formulations In Healthy Subjects
This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way. In part 2 of the study, depending on the results of part 1, either none, one or 2 of the formulations tested in part 1 will be tested comparing the same formulation when given either with or without food. Additionally, depending on the results of part 1 of the study, different doses of the formulations may be compared.
- Conditions
- Healthy
- Being tested
- tafamidis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tafamidisDrug
relative bioavailability
tafamidisDrug
fasted
tafamidisDrug
fed
| Study group | Role | What they receive |
|---|---|---|
| 4 soft gel capsules of 20 mg tafamidis meglumine | Experimental | Not described Receives: Drug: tafamidis |
| 48.8 mg tafamidis soft gel capsule formulation 1 | Experimental | Not described Receives: Drug: tafamidis |
| 48.8 mg tafamidis soft get capsule formulation 2 | Experimental | Not described Receives: Drug: tafamidis |
| 61 mg tafamidis soft gel capsule formulation 1 | Experimental | Not described Receives: Drug: tafamidis |
| 61 mg tafamidis soft gel capsule formulation 2 | Experimental | Not described Receives: Drug: tafamidis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time Curve (AUC)
Measured: 120 hours
Maximum Observed Plasma Concentration (Cmax)
Measured: 120 hours
Secondary outcomes (4)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Measured: 120 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 120 hours
Plasma Decay Half-Life (t1/2)
Measured: 120 hours
Area Under the Curve from Time zero to infinity
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
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 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
- None (open label)
- Enrolment
- 18 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
- NCT02534740
- Sponsor's protocol ID
- B3461052
- Other IDs
- 2015-002315-15, 2015
- Status last verified
- Dec 2015
- First submitted
- 25 Aug 2015
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Single Dose Study To Estimate The Relative Bioavailability And Food Effect Of PF-06291826 (Tafamidis) Following Administration Of New Soft Gelatin Capsule Oral Formulations In Healthy Subjects
- ClinicalTrials.gov ID
- NCT02534740
- Acronym / sponsor ID
- B3461052
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Aug 2015 (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 is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way. In part 2 of the study, depending on the results of part 1, either none, one or 2 of the formulations tested in part 1 will be tested comparing the same formulation when given either with or without food. Additionally, depending on the results of part 1 of the study, different doses of the formulations may be compared.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 4 soft gel capsules of 20 mg tafamidis meglumine | Experimental | Drug: tafamidis |
| 48.8 mg tafamidis soft gel capsule formulation 1 | Experimental | Drug: tafamidis |
| 48.8 mg tafamidis soft get capsule formulation 2 | Experimental | Drug: tafamidis |
| 61 mg tafamidis soft gel capsule formulation 1 | Experimental | Drug: tafamidis |
| 61 mg tafamidis soft gel capsule formulation 2 | Experimental | Drug: tafamidis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males or females of non-child bearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).
Key exclusion criteria (3 listed)
- Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
- Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
- Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.
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 |
|---|---|---|
| tafamidisrelative bioavailability | Drug | 4 soft gel capsules of 20 mg tafamidis meglumine, 48.8 mg tafamidis soft gel capsule formulation 1, 48.8 mg tafamidis soft get capsule formulation 2 |
| tafamidisfasted | Drug | 61 mg tafamidis soft gel capsule formulation 1, 61 mg tafamidis soft gel capsule formulation 2 |
| tafamidisfed | Drug | 48.8 mg tafamidis soft gel capsule formulation 1, 48.8 mg tafamidis soft get capsule formulation 2 |
Primary outcome
Area under the concentration-time Curve (AUC)
Time frame: 120 hours
Maximum Observed Plasma Concentration (Cmax)
Time frame: 120 hours
4 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 120 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 120 hours
Plasma Decay Half-Life (t1/2)
Time frame: 120 hours
Area Under the Curve from Time zero to infinity
Time frame: 120 hours
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 22 Dec 2015.
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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
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 Healthy, run by Pfizer at 1 site in Belgium.
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 22 Dec 2015. 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 Belgium. 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?
Area under the concentration-time Curve (AUC) (time frame: 120 hours). 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 22 Dec 2015.