A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants.

Part of paid clinical trials in Glendale, California.

Sponsor
Sanofi
Study ID
NCT05858788
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This is a cross-over, Phase 1, 3-treatment period single sequence study. The purpose of this study is to characterize pharmacokinetics (PK), safety, and tolerability of single ascending oral doses of SAR441566 in healthy male Japanese participants, 18-55 years of age.

Key Dates

First listed
May 15, 2023
Start date
May 15, 2023
Status verified
Sep 2025
Primary completion
Jul 17, 2023
Completion
Jul 17, 2023

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SAR441566
    Participants will receive single ascending doses of SAR441566 on day 1 of each 8-12-day cycle

Primary Outcome Measure

Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: Cmax [ Time Frame: From Day 1 to Day 5 of each period (5 days per period) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Parexel International-Site Number:8400001GlendaleCalifornia91206-

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