Prism Research-Site Number:8400001
Saint Paul, Minnesota, 55144, United States
NCT Number: NCT06064539
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.
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Saint Paul, Minnesota, 55144, United States
Study duration per participant approximately 16 days for Cohort 1 and approximately 18 days for Cohort 2.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Tablet, taken orally
Tablet, taken orally
Tablet, taken orally
Time frame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
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
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
Time frame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Time frame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Time frame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Time frame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Time frame: From Day 1 to Day 7 of Period 2
Time frame: From Day 1 to Day 7 of Period 2
Time frame: From Day 1 to Day 7 of Period 2
Time frame: From Day 1 to Day 7 of Period 2
Time frame: From Day 1 to Day 9 of Period 2
Time frame: From Day 1 to Day 9 of Period 2
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)
Sanofi
Industry
A Phase 1, Single-center, Open-label, Two-cohort, Two-period, One-sequence, Two Treatment, Drug-drug Interaction Study of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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