A Drug-Drug Interaction Study To Estimate The Effect Of Tafamidis On Rosuvastatin Pharmacokinetics

NCT ID: NCT04253353

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-06
• Study Completion Date: 2020-08-10

Brief Summary

Each subject will be given a single oral dose of rosuvastatin on Day 1 in Period 1. In Period 2, after a washout period of at least 5 days, each subject will receive oral doses of tafamidis twice daily (BID) on days 1 and 2, followed by tafamidis once daily (QD) on days 3 to 9 with an oral dose of rosuvastatin on Day 7. Rosuvastatin exposures will be compared between Periods 1 and 2 to estimate the effect of tafamidis on rosuvastatin PK in healthy subjects.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

rosuvastatin and tafamidis fixed sequence

• Period 1: rosuvastatin 10 mg (single oral administration)
• Washout
• Period 2: tafamidis 61 mg capsule(multiple doses, twice a day) + rosuvastatin 10 mg (single oral administration)

Group Type: EXPERIMENTAL

tafamidis

Intervention Type: DRUG

61 mg capsule

rosuvastatin

Intervention Type: DRUG

10 mg tablet

Interventions

tafamidis

61 mg capsule

Intervention Type: DRUG

rosuvastatin

10 mg tablet

Intervention Type: DRUG

Other Intervention Names

Vyndaqel; Crestor

Eligibility Criteria

Inclusion Criteria

• Male and female participants must be 18 to 60 years of age, inclusive, at the time of signing the informed consent document (ICD)
• Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiovascular tests
• Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

• History of hypersensitivity to rosuvastatin., asymptomatic, seasonal allergies at the time of dosing).
• Use of CYP2C19 inhibitors (eg, fluconazole, fluoxetine, fluvoxamine, ticlopidine omeprazole, voriconazole, cimetidine, esomeprazole, and felbamate) or inducers (eg, rifampin, ritonavir, efavirenz, enzalutamide, phenytoin, and St. John's Wort) within 28 days or 5 half-lives (whichever is longer) prior to dosing.
• Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or other inducers (eg, phenytoin, carbamazepine) within 28 days or 5 half-lives (whichever is longer) prior to dosing

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Brussels Clinical Research Unit

Brussels, Bruxelles-capitale, Région de, Belgium

Countries

Belgium

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=B3461075

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

Other Identifiers

B3461075

Identifier Type: -

Identifier Source: org_study_id