The purpose of the study is to assess the effect of capivasertib on the pharmacokinetics (PK) of oral rosuvastatin in healthy participants.
This study is an open-label, fixed-sequence, drug-drug interaction study of orally administered rosuvastatin in the presence and absence of capivasertib in healthy participants. The study will comprise: 1. A Screening Period of maximum 28 days. 2. Two Treatment Periods * Period 1: Participants will receive single oral dose of rosuvastatin. * Period 2: Participants will receive two single oral doses of capivasertib administered 12 hours apart, with the first capivasertib dose being concomitantly administered with a single oral dose of rosuvastatin. 3. A final Follow-up Visit within 7 to 10 days after the last study intervention administration. There will be a minimum washout period of at least 7 days between the first dose of rosuvastatin (in Treatment Period 1) and the second dose of rosuvastatin (in Treatment Period 2).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
Capivasertib will be administered orally twice in Period 2.
Rosuvastatin will be administered orally once in both Period 1 and Period 2.
Research Site
Baltimore, Maryland, United States
Area under concentration-time curve from time 0 to infinity (AUCinf) of rosuvastatin
To evaluate the PK (AUCinf) of rosuvastatin when administered orally alone and in combination with capivasertib.
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of rosuvastatin
To evaluate the PK (AUClast) of rosuvastatin when administered orally alone and in combination with capivasertib.
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Maximum observed drug concentration (Cmax) of rosuvastatin
To evaluate the PK (Cmax) of rosuvastatin when administered orally alone and in combination with capivasertib.
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Ratio of AUCinf (R AUCinf) of rosuvastatin
To evaluate the PK (R AUCinf) of rosuvastatin when administered orally alone and in combination with capivasertib.
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Ratio of AUClast (R AUClast) of rosuvastatin
To evaluate the PK (R AUClast) of rosuvastatin when administered orally alone and in combination with capivasertib.
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Ratio of Cmax (R Cmax) of rosuvastatin
To evaluate the PK (R Cmax) of rosuvastatin when administered orally alone and in combination with capivasertib.
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
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Terminal elimination half-life (t½λz) of rosuvastatin
To evaluate the PK (t½λz) of rosuvastatin when administered orally alone and in combination with capivasertib.
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Terminal elimination rate constant (λz) of rosuvastatin
To evaluate the PK (λz) of rosuvastatin when administered orally alone and in combination with capivasertib.
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
Time to reach maximum observed concentration (tmax) of rosuvastatin
To evaluate the PK (tmax) of rosuvastatin when administered orally alone and in combination with capivasertib.
Time frame: Period 1: Day 1 to Day 3 and Period 2: Day 1 to Day 3
AUClast of capivasertib
To evaluate the PK (AUClast) of capivasertib following oral dosing.
Time frame: Period 2: Day 1 to Day 3
Concentration at the end of a dosing interval (Ctrough) of capivasertib
To evaluate the PK (Ctrough) of capivasertib following oral dosing.
Time frame: Period 2: Day 1 to Day 3
Cmax of capivasertib
To evaluate the PK (Cmax) of capivasertib following oral dosing.
Time frame: Period 2: Day 1 to Day 3
Number of participants with adverse events (AEs) and serious AEs
To assess the safety and tolerability of capivasertib when administered with rosuvastatin.
Time frame: From Screening (Day -30 to Day -2) to follow-up visit (Day 10)
Change in serum bilirubin levels
To evaluate the effect of capivasertib dosing on total, conjugated, and unconjugated bilirubin levels.
Time frame: Day 1 (pre-capivasertib dose) to Day 3 (post-capivasertib dose)