Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants
Study Details
Study Description
Brief 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.
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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
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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)
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In Part 1c: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (high-fat)
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In Part 1d: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (standardized high-fat meal)
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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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1a 3 single ascending doses of SAR442168 or placebo in fasted and fed (high-fat breakfast) conditions |
Drug: Tolebrutinib
Tablet, oral
Other Names:
Drug: Placebo
Tablet, oral
|
| Experimental: Part 1b 2 single doses of SAR442168 under fed conditions (moderate-fat breakfast). |
Drug: Tolebrutinib
Tablet, oral
Other Names:
|
| Experimental: Part 1c 1 single dose of SAR442168 under fasting and fed conditions (high-fat breakfast). |
Drug: Tolebrutinib
Tablet, oral
Other Names:
|
| Experimental: Part 1d 1 single dose of SAR442168 under fasting and fed conditions (Standardized high-fat breakfast). |
Drug: Tolebrutinib
Tablet, oral
Other Names:
|
| Experimental: Part 2 3 ascending once-daily repeated single doses of SAR442168 or placebo for 14 days under fed conditions (moderate-fat breakfast) |
Drug: Tolebrutinib
Tablet, oral
Other Names:
Drug: Placebo
Tablet, oral
|
Outcome Measures
Primary Outcome Measures
- 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]
- Part 1b: Total (free and bound) SAR442168 concentrations in CSF [From Day 1 to Day 3]
- Part 1b: Total (free and bound) SAR442168 metabolite(s) concentrations in CSF [From Day 1 to Day 3]
- Part 1c and Part 1d: Maximum plasma concentration observed (Cmax) ratio fed/fast of SAR442168 [From Day 1 to Day approximately 14]
- Part 1c and Part1d: Cmax ratio fed/fasted of SAR442168 metabolite(s) [From Day 1 to Day approximately 14]
- 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]
- Part 1c and Part1d: AUC ratio fed/fast of SAR442168 metabolite(s) [From Day 1 to Day approximately 14]
Secondary Outcome Measures
- All Parts: Cmax of SAR442168 [From Day 1 to Day approximately 14]
- All Parts: Cmax of SAR442168 metabolite(s) [From Day 1 to Day approximately 14]
- Part 1a, Part 1b and Part 2: tmax of SAR442168 [From Day 1 to Day approximately 14]
- Part 1a, Part 1b and Part 2: tmax of SAR442168 metabolite(s) [From Day 1 to Day approximately 14]
- Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168 [From Day 1 to Day approximately 14]
- Part 1a, Part 1b, Part1c and Part 1d: AUC of SAR442168 metabolite(s) [From Day 1 to Day approximately 14]
- Part 2: AUC0-tau for SAR442168 [From Day 1 to Day approximately 14]
Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours)
- Part 2: AUC0-tau for SAR442168 metabolite(s) [From Day 1 to Day approximately 14]
Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours)
- 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]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New Orleans Clinical Research Site Number : 8400001 | Knoxville | Tennessee | United States | 37920 |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TDU16831-TDR16862