A Study Comparing Amounts of Tafamidis In The Blood Witho... | NCT02697864

Studies
A Study Comparing Amounts of Tafamidis In The Blood Without Food

NCT02697864

Sponsor

Pfizer

Status

Completed

Last Update Posted

Jul 24, 2017Actual

Enrollment

12Actual

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
2016-000295-16	EudraCT Number

Status Module

Record Verification Date

Jul 2017

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

Apr 2016Actual

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Feb 29, 2016

First Submission Date that Met QC Criteria

Feb 29, 2016

First Posted Date

Mar 3, 2016Estimated

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

Jul 20, 2017

Last Update Posted Date

Jul 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

3 different formulations and doses 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.

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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
48.8 mgA tafamidis free acid tablet	Experimental	Drug: tafamidis
58 mgA tafamidis free acid tablet	Experimental	Drug: tafamidis
4 soft gel capsules of 20 mg tafamidis meglumine	Experimental	Drug: tafamidis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tafamidis	Drug		4 soft gel capsules of 20 mg tafamidis meglumine 48.8 mgA tafamidis free acid tablet 58 mgA tafamidis free acid tablet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the concentration-time Curve (AUC)		120 hours
Maximum Observed Plasma Concentration (Cmax)		120 hours

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)		120 hours
Mean residence time (MRT)		120 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

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.
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