HealthyPhase 1NCT01369836
Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western Subjects
A Phase 1 study testing Tafamidis meglumin in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is the following: To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered tafamidis in Japanese and Western healthy volunteers at single dose. To compare Japanese and Western PK profiles. 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 meglumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Aug 2011
- 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 male or females.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
Who cannot join
- Pregnant or nursing females.
- Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Glendale, California, 91206
About this study
Official title: An Investigator And Subject-Blind Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06291826 (Tafamidis) After Single Oral Administration To Japanese And Western Healthy Subjects
The purpose of this study is the following:
- To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered tafamidis in Japanese and Western healthy volunteers at single dose.
- To compare Japanese and Western PK profiles.
- Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a validated ex vivo assay.
- Conditions
- Healthy
- Being tested
- Tafamidis meglumin, Placebo
- Keywords
- Tafamidis, Pharmacokinetics, TTR stabilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tafamidis megluminDrug
Also called PF-06291826
A single oral dose of 20 mg capsule
Tafamidis megluminDrug
Also called PF-06291826
A single oral dose of 40 mg capsule.
PlaceboDrug
A single oral dose of matched placebo.
| Study group | Role | What they receive |
|---|---|---|
| 20 mg soft gelatin capsule | Experimental | Not described Receives: Drug: Tafamidis meglumin |
| 40 mg (20 mg*2) soft gelatin capsule | Experimental | Not described Receives: Drug: Tafamidis meglumin |
| Placebo | Active comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of tafamidis over time (AUClast).
Measured: 2 months
Plasma concentration of tafamidis over time (Cmax).
Measured: 2 months
Plasma concentration of tafamidis over time (Tmax).
Measured: 2 months
If data permit, AUCinf and t1/2 will be determined.
Measured: 2 months
Secondary outcomes (1)
The percent stabilization of TTR tetramer will be defined at Cmax in each subject and compared between Japanese volunteers and Western volunteers.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionAug 2011
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 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
- NCT01369836
- Sponsor's protocol ID
- B3461009
- Status last verified
- Sep 2011
- First submitted
- 6 Jun 2011
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator And Subject-Blind Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06291826 (Tafamidis) After Single Oral Administration To Japanese And Western Healthy Subjects
- ClinicalTrials.gov ID
- NCT01369836
- Acronym / sponsor ID
- B3461009
- Conditions
- Healthy
- Keywords
- Tafamidis, Pharmacokinetics, TTR stabilization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 9 Jun 2011 (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 the following:
- To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered tafamidis in Japanese and Western healthy volunteers at single dose.
- To compare Japanese and Western PK profiles.
- Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a validated ex vivo assay.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20 mg soft gelatin capsule | Experimental | Drug: Tafamidis meglumin |
| 40 mg (20 mg*2) soft gelatin capsule | Experimental | Drug: Tafamidis meglumin |
| Placebo | Active comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or females.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
Key exclusion criteria (2 listed)
- Pregnant or nursing females.
- Females of childbearing potential who are unwilling or unable to use an acceptable 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 |
|---|---|---|
| Tafamidis megluminAlso: PF-06291826A single oral dose of 20 mg capsule | Drug | 20 mg soft gelatin capsule |
| Tafamidis megluminAlso: PF-06291826A single oral dose of 40 mg capsule. | Drug | 40 mg (20 mg*2) soft gelatin capsule |
| PlaceboA single oral dose of matched placebo. | Drug | Placebo |
Primary outcome
Plasma concentration of tafamidis over time (AUClast).
Time frame: 2 months
Plasma concentration of tafamidis over time (Cmax).
Time frame: 2 months
Plasma concentration of tafamidis over time (Tmax).
Time frame: 2 months
If data permit, AUCinf and t1/2 will be determined.
Time frame: 2 months
1 secondary outcome
The percent stabilization of TTR tetramer will be defined at Cmax in each subject and compared between Japanese volunteers and Western volunteers.
Time frame: 2 months
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 13 Sep 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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.
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 meglumin in people with Healthy, run by Pfizer 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 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 13 Sep 2011. 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 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?
Plasma concentration of tafamidis over time (AUClast). (time frame: 2 months). The study lists 4 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 13 Sep 2011.