A Study Comparing Amounts of Tafamidis In The Blood With Or Without Food

NCT02534740 | Completed Phase 1

• 2 other identifiers: B34610522015-002315-15
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time Curve (AUC)

  120 hours

• Maximum Observed Plasma Concentration (Cmax)

  120 hours

Secondary Outcomes (4)

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

  120 hours

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  120 hours

• Plasma Decay Half-Life (t1/2)

  120 hours

• Area Under the Curve from Time zero to infinity

  120 hours

Study Arms (5)

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

Interventions

tafamidis DRUG

relative bioavailability

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

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

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: August 25, 2015
• First Posted: August 28, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

BE (1)