Phase I Safety, Pharmacokinetics and Bioavailability Study Comparing Rate and Extent of Absorption of Two Different Forms of Tafamidis (PF-6291826)

NCT03662191 | Completed Phase 1 FDA Drug

• 3 other identifiers: B34610592017-004935-35BA STUDY
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

2 different formulations and 4 different single doses of tafamidis will be compared. All subjects will receive both formulations and 3 different doses. Subjects will be fasted before taking the drug. After swallowing single dose of tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After another 16 days, all subjects will repeat the procedure twice, each time with the other formulation/dose.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 1. Area under the plasma concentration-time profile from time 0 extrapolated to infinite time (AUCinf)

  0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs

• 2. Maximum Observed Plasma Concentration (Cmax)

  0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs

Secondary Outcomes (3)

• 1. Area under the plasma concentration-time profile from time 0 to 24 hours post-dose (AUC24)

  0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs

• 2. Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)

  0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs

• 3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

  0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs

Study Arms (4)

Treatment A

EXPERIMENTAL

4 × 20 mg commercial tafamidis meglumine administered as soft gelatin capsules under fasted conditions

Drug: Tafamidis

Treatment B

EXPERIMENTAL

10 mgA tafamidis free acid administered as a wet-milled suspension under fasted conditions

Drug: Tafamidis

Treatment C

EXPERIMENTAL

a dose of tafamidis free acid projected to be an equivalent of 4 × 20 mg commercial tafamidis meglumine administered as a wet-milled suspension under fasted conditions

Drug: Tafamidis

Treatment D

EXPERIMENTAL

a dose of tafamidis free acid projected to be an equivalent of 5 × 20 mg commercial tafamidis meglumine administered as a wet-milled suspension under fasted conditions

Drug: Tafamidis

Interventions

Tafamidis DRUG

bioavailability study

Treatment A; Treatment B; Treatment C; Treatment D

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:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• 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 the study.
• Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.

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: August 23, 2018
• First Posted: September 7, 2018
• Study Start: September 28, 2018
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: February 11, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)