This is a Phase 1, single-center, open-label, non-randomized study to assess the effects of CYP2C8 inhibition using gemfibrozil, and CYP3A4 and CYP2C8 induction using rifampicin on the pharmacokinetics of SAR442168 in healthy male participants aged 18 to 45 years.
Study duration per participant approximately 16 days for Cohort 1 and approximately 18 days for Cohort 2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Tablet, taken orally
Tablet, taken orally
Tablet, taken orally
Prism Research-Site Number:8400001
Saint Paul, Minnesota, United States
Pharmacokinetics: AUClast of SAR442168
AUC up to the last measurable concentration
Time frame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Pharmacokinetics: AUC of SAR442168
Area under the curve, reflects the concentration of drug
Time frame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Pharmacokinetics: Maximum plasma concentration observed (Cmax) of SAR442168
Time frame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Pharmacokinetics: Cmax of SAR442168 metabolite(s)
Time frame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Pharmacokinetics: AUC of SAR442168 metabolite(s)
Time frame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Pharmacokinetics: Time to reach Cmax (tmax) of SAR442168
Time frame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Pharmacokinetics: tmax of SAR442168 metabolite(s)
Time frame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Pharmacokinetics: Cmax of gemfibrozil
Time frame: From Day 1 to Day 7 of Period 2
Pharmacokinetics: Cmax of gemfibrozil 1-O-glucuronide
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Time frame: From Day 1 to Day 7 of Period 2
Pharmacokinetics: tmax of gemfibrozil
Time frame: From Day 1 to Day 7 of Period 2
Pharmacokinetics: tmax of gemfibrozil 1-O-glucuronide
Time frame: From Day 1 to Day 7 of Period 2
Pharmacokinetics: Cmax of rifampicin
Time frame: From Day 1 to Day 9 of Period 2
Pharmacokinetics: tmax of rifampicin
Time frame: From Day 1 to Day 9 of Period 2
Numbers of participants with adverse events (AEs)
Time frame: From baseline to End of Study (i.e. Period 2 Day 16 days in Cohort 1, and Period 2 Day18 days in Cohort 2)