Status:
COMPLETED
Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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 pharmacokinetic...
Detailed Description
Study duration per participant approximately 16 days for Cohort 1 and approximately 18 days for Cohort 2.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06064539
Start Date
May 18 2020
End Date
July 8 2020
Last Update
September 17 2025
Active Locations (1)
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1
Prism Research-Site Number:8400001
Saint Paul, Minnesota, United States, 55144