The purpose of this study is to measure the effect of ticagrelor on the pharmacokinetics (PK) of rosuvastatin in healthy participants.
This study will be conducted at a single Clinical Unit. It includes 2 parallel arms (one for each rosuvastatin dose) and 2 treatment periods. The study will comprise: * A Screening Period of maximum 28 days. * Period 1: It will start on Day -1. A single dose of rosuvastatin (dose 1 or dose 2) will be administered on Day 1 followed by PK sampling of rosuvastatin for 96 hours. Participants will be admitted to the Clinical Unit on Study Day -1. Period 1 will end on Study Day 5. * Period 2: It will start on Study Day 6. A second single dose of rosuvastatin (dose 1 or dose 2) will be administered on Day 6 followed by PK sampling of rosuvastatin for 120 hours. Ticagrelor 90 mg, twice a day will be started on Day 6 (administered concomitantly with rosuvastatin) and administered through Day 10. Period 2 will end on Study Day 12. * A Follow-up Visit, 4 to 7 days after discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
28
Participants will receive rosuvastatin (dose 1 or dose 2) orally as a single dose on Day 1 in Period 1 and Day 6 in Period 2.
Participants in each arm will receive ticagrelor 90 mg orally BID from Day 6 to Day 10.
Research Site
Berlin, Germany
Area under concentration-time curve from time 0 to infinity (AUCinf)
To assess the effect of ticagrelor on plasma PK (AUCinf) of rosuvastatin dose 1 and dose 2 separately, in healthy participants.
Time frame: From Day 1 to Day 11
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To assess the effect of ticagrelor on plasma PK (AUClast) of rosuvastatin dose 1 and dose 2 separately, in healthy participants.
Time frame: From Day 1 to Day 11
Maximum observed drug concentration (Cmax)
To assess the effect of ticagrelor on plasma PK (Cmax) of rosuvastatin dose 1 and dose 2 separately, in healthy participants.
Time frame: From Day 1 to Day 11
Number of participants with adverse events (AEs)
To examine the safety and tolerability of rosuvastatin alone and in combination with ticagrelor.
Time frame: Approximately 7 weeks
Terminal elimination half-life (t1/2)
To assess the effect of ticagrelor on the PK (t1/2) of rosuvastatin in healthy participants.
Time frame: From Day 1 to Day 11
Terminal rate constant (parent only) (λz)
To assess the effect of ticagrelor on the PK (λz) of rosuvastatin in healthy participants.
Time frame: From Day 1 to Day 11
Time to reach maximum observed concentration (tmax)
To assess the effect of ticagrelor on the PK (tmax) of rosuvastatin in healthy participants.
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Time frame: From Day 1 to Day 11
Amount of drug excreted (Ae)
To assess the effect of ticagrelor on the urine PK (Ae) of rosuvastatin in healthy participants.
Time frame: From Day 1 to Day 11
Renal clearance (Clrenal)
To assess the effect of ticagrelor on the urine PK (Clrenal) of rosuvastatin in healthy participants.
Time frame: From Day 1 to Day 11
Percent of dose excreted
To assess the effect of ticagrelor on the urine PK of rosuvastatin in healthy participants.
Time frame: From Day 1 to Day 11