A Study Comparing Amounts of 2 Different Forms of Tafamid... | NCT03266705

Studies
A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood

NCT03266705

Sponsor

Pfizer

Status

Completed

Last Update Posted

May 14, 2018Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy

Interventions

tafamidis

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2017-002572-15	EudraCT Number

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2017Actual

Primary Completion Date

Feb 15, 2018Actual

Completion Date

Mar 1, 2018Actual

First Submitted Date

Aug 28, 2017

First Submission Date that Met QC Criteria

Aug 28, 2017

First Posted Date

Aug 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2018

Last Update Posted Date

May 14, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

2 different formulations and doses of tafamidis will be compared. All subjects will receive both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they will take tafamidis twice, 12 hours apart and then once a day for the next 5 days. Subjects will be fasted before taking the drug. Blood samples will be taken to measure the amount of tafamidis starting on day 7 and ending on day 8. At least 16 days after the first formulation/dose is given, all subjects will repeat the procedure with the other formulation/dose.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
61 mgA tafamidis free acid soft gelatin capsule	Experimental		Drug: tafamidis
4x20 mg tafamidis meglumine soft gelatin capsule	Experimental		Drug: tafamidis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tafamidis	Drug	bioequivalence study	4x20 mg tafamidis meglumine soft gelatin capsule 61 mgA tafamidis free acid soft gelatin capsule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the concentration-time curve (AUC)		24 hours
maximum observed plasma concentration (Cmax)		24 hours

Secondary Outcomes

Measure	Description	Time Frame
minimum observed plasma concentration (Cmin)		24 hours
Time to maximum observed plasma concentration (Tmax)		24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy males of females of non-childbearing potential
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)

Exclusion Criteria:

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.
Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer)
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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Clinical Research Unit		Brussels		B-1070	Belgium

References Module

Citations

Not provided