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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
61 mg capsule
10 mg tablet
Brussels Clinical Research Unit
Brussels, Bruxelles-capitale, Région de, Belgium
Area under the plasma concentration-time profile from time 0 extrapolated to infinity (AUCinf) for rosuvastatin
AUClast + (Clast/kel)
Time frame: 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.
Apparent renal clearance (CLr) for rosuvastatin
Ae/AUClast for extravascular dosing
Time frame: 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.
Number of subjects with a clinically significant change in vital sign measurements from baseline
Time frame: Baseline through Day 10 of period 2
Number of subjects with a clinically significant change in laboratory tests from baseline
Time frame: Baseline through Day 10 of period 2
Number of subjects with treatment emergent adverse events
Time frame: Baseline through Day 28 follow up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.