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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06064539
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.7
• Patients Per Site Per Month: 17.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Tolebrutinib; Drug: gemfibrozil; Drug: rifampicin	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 18, 2020
• Actual Primary Completion Date: Jul 8, 2020
• Actual Study Completion Date: Jul 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 SAR442168 administered alone and together with gemfibrozil. 1 day washout for each administration of SAR442168.	Drug: Tolebrutinib; Tablet, taken orally; Drug: gemfibrozil; Tablet, taken orally
Experimental: Cohort 2 SAR442168 administered alone and together with rifampicin. 1 day washout for each administration of SAR442168.	Drug: Tolebrutinib; Tablet, taken orally; Drug: rifampicin; Tablet, taken orally

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics: AUClast of SAR442168 [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

2. Pharmacokinetics: AUC of SAR442168 [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

Secondary Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

6. Pharmacokinetics: Cmax of gemfibrozil [From Day 1 to Day 7 of Period 2]

7. Pharmacokinetics: Cmax of gemfibrozil 1-O-glucuronide [From Day 1 to Day 7 of Period 2]

8. Pharmacokinetics: tmax of gemfibrozil [From Day 1 to Day 7 of Period 2]

9. Pharmacokinetics: tmax of gemfibrozil 1-O-glucuronide [From Day 1 to Day 7 of Period 2]

10. Pharmacokinetics: Cmax of rifampicin [From Day 1 to Day 9 of Period 2]

11. Pharmacokinetics: tmax of rifampicin [From Day 1 to Day 9 of Period 2]

12. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prism Research-Site Number:8400001	Saint Paul	Minnesota	United States	55144

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT06064539
• Other Study ID Numbers: INT16726; U1111-1244-2759
• First Posted: Oct 3, 2023
• Last Update Posted: Oct 3, 2023
• Last Verified: Sep 22, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Multiple Sclerosis; Rifampin; Gemfibrozil

Study Results

No Results Posted as of Oct 3, 2023