Rheumatoid Arthritis
Conditions
Brief summary
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.
Detailed description
The duration of the study for a participant will be up to approximately 65 days.
Interventions
DRUGSAR441566
Tablet
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Japanese participants whose Japanese ethnicity is defined according to the following criteria: born in Japan or born outside of Japan, and are descendent of 4 ethnic Japanese grandparents who were all born in Japan. * Male participants between the ages of 18 and 55 years, inclusive * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination including 12-lead ECG, and clinical laboratory tests) * Body weight between 50.0 and 100.0 kg, inclusive, and body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive.
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: * Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, dermatological (including phototoxic dermatitis), osteomuscular, articular, psychiatric, systemic, ocular, immune disorders or infectious disease, or signs of acute illness. * Receipt of live (attenuated) vaccines within 3 months and/or non live vaccines (eg, COVID-19 vaccination) within 4 weeks prior to first dose on Day 1, or planned to receive these vaccines at any time throughout the study. * History of tuberculosis and/or a positive QuantiFERON-TB Gold (QFT) test. * Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibody (anti-HBc Ab), anti-hepatitis C virus antibody (anti-HCV Ab), anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab), SARS-CoV-2 * Any medication within 14 days before inclusion (before first study treatment administration) or within 5 times the elimination half-life or pharmacodynamic half-life of the medication whichever the longest. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: Cmax | From Day 1 to Day 5 of each period (5 days per period) | Maximum plasma concentration observed |
| Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUClast | From Day 1 to Day 5 of each period (5 days per period) | Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time Tlast (AUClast) |
| Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUC | From Day 1 to Day 5 of each period (5 days per period) | Area under the plasma concentration versus time curve extrapolated to infinity (AUC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs) | Up to end of study visit (which will occur at latest day 37 of study) | Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including Serious AE and AE of Special Interest |
Countries
United States
Outcome results
None listed