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

Rheumatoid Arthritis Clinical Trial

Official title:

A Phase 1, Open Label, 3-treatment Period, 1-sequence, Cross-over Study to Evaluate Pharmacokinetics, Safety, and Tolerability After Single Ascending Oral Doses of SAR441566 in Healthy Adult Japanese Male Participants.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05858788
• Other study ID #: PKM17860
• Secondary ID: U1111-1287-6944
• Status: Completed
• Phase: Phase 1
• Start date: May 15, 2023
• Est. completion date: July 17, 2023

Study information

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

Clinical Trial 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.

Description:

The duration of the study for a participant will be up to approximately 65 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 17, 2023
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• SAR441566
Tablet

Locations

Country	Name	City	State
United States	Parexel International-Site Number:8400001	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: Cmax	Maximum plasma concentration observed	From Day 1 to Day 5 of each period (5 days per period)
Primary	Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUClast	Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time Tlast (AUClast)	From Day 1 to Day 5 of each period (5 days per period)
Primary	Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUC	Area under the plasma concentration versus time curve extrapolated to infinity (AUC)	From Day 1 to Day 5 of each period (5 days per period)
Secondary	Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs)	Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including Serious AE and AE of Special Interest	Up to end of study visit (which will occur at latest day 37 of study)