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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Tafamidis

• Registration Number: NCT03662191
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Study Start: 2018-09-28
• Primary Completion: 2019-01-10
• Study Completion: 2019-01-10
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment B	Tafamidis	10 mgA tafamidis free acid administered as a wet-milled suspension under fasted conditions
Treatment A	Tafamidis	4 × 20 mg commercial tafamidis meglumine administered as soft gelatin capsules under fasted conditions
Treatment D	Tafamidis	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
Treatment C	Tafamidis	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium