Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants

Multiple Sclerosis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study of the Tolerability and Pharmacokinetics of Ascending Single and 14-day Repeated Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06106074
• Other study ID #: TDU16831-TDR16862
• Status: Completed
• Phase: Phase 1
• Start date: August 10, 2020
• Est. completion date: May 23, 2022

Study information

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

Clinical Trial Summary

This is a randomized, placebo-controlled, four-part, Phase I, first in human (FIH) study to assess the tolerability and pharmacokinetics (PK) of ascending single and 14-day repeated oral doses of SAR442168 with a food effect investigation in healthy adult participants.

• In Part 1a: The tolerability and safety of SAR442168 and the pharmacokinetic parameters of SAR442168 and metabolite(s)after ascending single oral doses in fasted and fed conditions

• In Part 1b: The relationship of PK of SAR442168 and metabolite(s) in cerebrospinal fluid (CSF) to that in plasma after single oral doses given in fed conditions (moderate-fat meal)

• In Part 1c: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (high-fat)

• In Part 1d: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (standardized high-fat meal)

• In Part 2: The tolerability and safety of SAR442168 and the pharmacokinetic parameters of SAR442168 and metabolite(s) after 14-day ascending repeated oral doses of SAR442168 given in fed conditions (moderate-fat meal).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: May 23, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Having given written informed consent prior to undertaking any study-related procedure.

Exclusion Criteria:

• 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, oral
• Placebo
Tablet, oral

Locations

Country	Name	City	State
United States	New Orleans Clinical Research Site Number : 8400001	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1a and Part 2: Number of participants with Adverse Events (AEs) and treatment-emergent adverse events (TEAEs)		Part 1a: Day 1 to approximately Day 14 Part 2: Day 1 to approximately Day 21
Primary	Part 1b: Total (free and bound) SAR442168 concentrations in CSF		From Day 1 to Day 3
Primary	Part 1b: Total (free and bound) SAR442168 metabolite(s) concentrations in CSF		From Day 1 to Day 3
Primary	Part 1c and Part 1d: Maximum plasma concentration observed (Cmax) ratio fed/fast of SAR442168		From Day 1 to Day approximately 14
Primary	Part 1c and Part1d: Cmax ratio fed/fasted of SAR442168 metabolite(s)		From Day 1 to Day approximately 14
Primary	Part 1c and Part 1d: Area under the plasma concentration versus time curve (AUC) ratio fed/fast of SAR442168		From Day 1 to Day approximately 14
Primary	Part 1c and Part1d: AUC ratio fed/fast of SAR442168 metabolite(s)		From Day 1 to Day approximately 14
Secondary	All Parts: Cmax of SAR442168		From Day 1 to Day approximately 14
Secondary	All Parts: Cmax of SAR442168 metabolite(s)		From Day 1 to Day approximately 14
Secondary	Part 1a, Part 1b and Part 2: tmax of SAR442168		From Day 1 to Day approximately 14
Secondary	Part 1a, Part 1b and Part 2: tmax of SAR442168 metabolite(s)		From Day 1 to Day approximately 14
Secondary	Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168		From Day 1 to Day approximately 14
Secondary	Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168 metabolite(s)		From Day 1 to Day approximately 14
Secondary	Part 2: AUC0-tau for SAR442168	Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours)	From Day 1 to Day approximately 14
Secondary	Part 2: AUC0-tau for SAR442168 metabolite(s)	Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours)	From Day 1 to Day approximately 14
Secondary	Part 1b, Part1c and 1d: Number of participants with Adverse Events (AEs) and treatment-emergent adverse events (TEAEs)		From Day 1 to Day approximately 14