Clinical trial NCT04253353: A Drug-Drug Interaction Study To Estimate The Effect Of Tafamidis On Rosuvastatin Pharmacokinetics
Official title: A PHASE 1, OPEN LABEL, TWO-PERIOD, TWO-TREATMENT, FIXED-SEQUENCE STUDY TO ESTIMATE THE EFFECT OF A MULTIPLE ORAL DOSE OF TAFAMIDIS ON ROSUVASTATIN PHARMACOKINETICS IN HEALTHY PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Area under the plasma concentration-time profile from time 0 extrapolated to infinity (AUCinf) for rosuvastatin
timeFrame: 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.
measure: Apparent renal clearance (CLr) for rosuvastatin
timeFrame: 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.
Secondary outcomes:
measure: Number of subjects with a clinically significant change in vital sign measurements from baseline
timeFrame: Baseline through Day 10 of period 2
measure: Number of subjects with a clinically significant change in laboratory tests from baseline
timeFrame: Baseline through Day 10 of period 2
measure: Number of subjects with treatment emergent adverse events
timeFrame: Baseline through Day 28 follow up
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Brussels Clinical Research Unit
state: Bruxelles-capitale, Région DE
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: