A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood

NCT03280173 | Completed Phase 1 FDA Drug

• 2 other identifiers: B34610542017-002769-23
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

2 different formulations of tafamidis will be compared under both fed and fasted conditions. Subjects will be fasted overnight or fed. After swallowing one of the tafamidis formulations, tafamidis blood concentrations will be measured periodically for 8 days. After 16 days, subjects will take a different formulation in the fed or fasted state or take the same formulation in the opposite feeding condition. This will be repeated, 16 days apart, until all subjects have taken each formulation both fed and fasted.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve 0-72 hours (AUC72)

  72 hrs

• maximum observed plasma concentration (Cmax)

  168 hrs

Secondary Outcomes (5)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  168 hrs

• Mean residence time (MRT)

  168 hrs

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  168 hrs

• Plasma Decay Half-Life (t1/2)

  168 hrs

• Area under the curve from zero to infinity (AUCinf)

  168 hrs

Study Arms (4)

61 mgA tafamidis free acid soft gelatin capsule fed

EXPERIMENTAL

fasted

Drug: tafamidis

61 mgA tafamidis free acid soft gelatin capsule fasted

EXPERIMENTAL

fed

Drug: tafamidis

4 × 20 mg tafamidis meglumine soft gelatin capsules fed

EXPERIMENTAL

fed

Drug: tafamidis

4 × 20 mg tafamidis meglumine soft gelatin capsules fasted

EXPERIMENTAL

fasted

Drug: tafamidis

Interventions

tafamidis DRUG

bioavailability study

4 × 20 mg tafamidis meglumine soft gelatin capsules fasted; 4 × 20 mg tafamidis meglumine soft gelatin capsules fed; 61 mgA tafamidis free acid soft gelatin capsule fasted; 61 mgA tafamidis free acid soft gelatin capsule fed

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

tafamidis

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 12, 2017
• Study Start: September 29, 2017
• Primary Completion: February 23, 2018
• Study Completion: February 23, 2018
• Last Updated: April 6, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)