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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SAR441566
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Parexel International-Site Number:8400001

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SAR441566

Arm Description

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

Outcomes

Primary Outcome Measures

Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: Cmax
Maximum plasma concentration observed
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)
Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUC
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)

Secondary Outcome Measures

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

Full Information

First Posted
May 5, 2023
Last Updated
August 18, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT05858788
Brief Title
A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
July 17, 2023 (Actual)
Study Completion Date
July 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAR441566
Arm Type
Experimental
Arm Description
Participants will receive single ascending doses of SAR441566 on day 1 of each 8-12-day cycle
Intervention Type
Drug
Intervention Name(s)
SAR441566
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: Cmax
Description
Maximum plasma concentration observed
Time Frame
From Day 1 to Day 5 of each period (5 days per period)
Title
Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUClast
Description
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time Tlast (AUClast)
Time Frame
From Day 1 to Day 5 of each period (5 days per period)
Title
Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUC
Description
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
Time Frame
From Day 1 to Day 5 of each period (5 days per period)
Secondary Outcome Measure Information:
Title
Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs)
Description
Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including Serious AE and AE of Special Interest
Time Frame
Up to end of study visit (which will occur at latest day 37 of study)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Parexel International-Site Number:8400001
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.

Learn more about this trial

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

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