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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: tafamidis; Drug: rosuvastatin

• Registration Number: NCT04253353
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Study Start: 2020-02-06
• Primary Completion: 2020-08-10
• Study Completion: 2020-08-10
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
rosuvastatin and tafamidis fixed sequence	tafamidis	* 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)
rosuvastatin and tafamidis fixed sequence	rosuvastatin	* 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)

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time profile from time 0 extrapolated to infinity (AUCinf) for rosuvastatin	Hours 0, at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose in Periods 1 and 2.	AUClast + (Clast/kel)
Apparent renal clearance (CLr) for rosuvastatin	Hours 0, at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose in Periods 1 and 2 for AUClast. For Ae, hours 0-24, 24-48, 48-72 hours post-dose in Periods 1 and 2.	Ae/AUClast for extravascular dosing

Secondary Outcome Measures

Name	Time	Method
Number of subjects with a clinically significant change in laboratory tests from baseline	Baseline through Day 10 of period 2
Number of subjects with a clinically significant change in vital sign measurements from baseline	Baseline through Day 10 of period 2
Number of subjects with treatment emergent adverse events	Baseline through Day 28 follow up

Trial Locations

Locations (1)

Brussels Clinical Research Unit; 🇧🇪 Brussels, Bruxelles-capitale, Région DE, Belgium