Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06064539
• Other study ID #: INT16726
• Secondary ID: U1111-1244-2759
• Status: Completed
• Phase: Phase 1
• Start date: May 18, 2020
• Est. completion date: July 8, 2020

Study information

• Verified date: September 22, 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 8, 2020
• Est. primary completion date: July 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• Tolebrutinib
Tablet, taken orally
• gemfibrozil
Tablet, taken orally
• rifampicin
Tablet, taken orally

Locations

Country	Name	City	State
United States	Prism Research-Site Number:8400001	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: AUClast of SAR442168	AUC up to the last measurable concentration	Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Primary	Pharmacokinetics: AUC of SAR442168	Area under the curve, reflects the concentration of drug	Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Secondary	Pharmacokinetics: Maximum plasma concentration observed (Cmax) of SAR442168		Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Secondary	Pharmacokinetics: Cmax of SAR442168 metabolite(s)		Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Secondary	Pharmacokinetics: AUC of SAR442168 metabolite(s)		Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Secondary	Pharmacokinetics: Time to reach Cmax (tmax) of SAR442168		Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Secondary	Pharmacokinetics: tmax of SAR442168 metabolite(s)		Cohort 1: day1 period 1 to day 7 period 2; Cohort 2: day1 period 1 to day 9 period 2
Secondary	Pharmacokinetics: Cmax of gemfibrozil		From Day 1 to Day 7 of Period 2
Secondary	Pharmacokinetics: Cmax of gemfibrozil 1-O-glucuronide		From Day 1 to Day 7 of Period 2
Secondary	Pharmacokinetics: tmax of gemfibrozil		From Day 1 to Day 7 of Period 2
Secondary	Pharmacokinetics: tmax of gemfibrozil 1-O-glucuronide		From Day 1 to Day 7 of Period 2
Secondary	Pharmacokinetics: Cmax of rifampicin		From Day 1 to Day 9 of Period 2
Secondary	Pharmacokinetics: tmax of rifampicin		From Day 1 to Day 9 of Period 2
Secondary	Numbers of participants with adverse events (AEs)		From baseline to End of Study (i.e. Period 2 Day 16 days in Cohort 1, and Period 2 Day18 days in Cohort 2)