Clinical trial NCT06064539: Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-10-03
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Study duration per participant approximately 16 days for Cohort 1 and approximately 18 days for Cohort 2.

Eligibility criteria: Inclusion Criteria:

* Male participant, between 18 and 45 years of age, inclusive.
* Body weight between 50.0 and 100.0 kg, inclusive, body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
* Having given written informed consent prior to undertaking any study-related procedure.

Exclusion Criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
* Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Participants with known hypersensitivity to any component of the IMP formulation or allergic disease diagnosed and treated by a physician.
* Any medication (including St John's Wort and ginseng) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
* Any contraindications to gemfibrozil or rifampicin, according to the applicable labelling.
* Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Pharmacokinetics: AUClast of SAR442168
timeFrame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
measure: Pharmacokinetics: AUC of SAR442168
timeFrame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Secondary outcomes:
measure: Pharmacokinetics: Maximum plasma concentration observed (Cmax) of SAR442168
timeFrame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
measure: Pharmacokinetics: Cmax of SAR442168 metabolite(s)
timeFrame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
measure: Pharmacokinetics: AUC of SAR442168 metabolite(s)
timeFrame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
measure: Pharmacokinetics: Time to reach Cmax (tmax) of SAR442168
timeFrame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
measure: Pharmacokinetics: tmax of SAR442168 metabolite(s)
timeFrame: Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
measure: Pharmacokinetics: Cmax of gemfibrozil
timeFrame: From Day 1 to Day 7 of Period 2
measure: Pharmacokinetics: Cmax of gemfibrozil 1-O-glucuronide
timeFrame: From Day 1 to Day 7 of Period 2
measure: Pharmacokinetics: tmax of gemfibrozil
timeFrame: From Day 1 to Day 7 of Period 2
measure: Pharmacokinetics: tmax of gemfibrozil 1-O-glucuronide
timeFrame: From Day 1 to Day 7 of Period 2
measure: Pharmacokinetics: Cmax of rifampicin
timeFrame: From Day 1 to Day 9 of Period 2
measure: Pharmacokinetics: tmax of rifampicin
timeFrame: From Day 1 to Day 9 of Period 2
measure: Numbers of participants with adverse events (AEs)
timeFrame: From baseline to End of Study (i.e. Period 2 Day 16 days in Cohort 1, and Period 2 Day18 days in Cohort 2)
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Prism Research-Site Number:8400001
state: Minnesota
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: