A single-sequence, 3-period, cross-over, Phase 1, single-center, open-label, non-randomized, dose escalation study to evaluate the pharmacokinetics, safety, and tolerability of orally administered SAR443122 in healthy Japanese and Chinese male adult participants
- Conditions
- Not Applicable
- Registration Number
- KCT0006597
- Lead Sponsor
- Sanofi-Aventis Korea
- Brief Summary
When healthy male adults received 3 single ascending doses of SAR443122 orally in fasted conditions, the amount of SAR443122 in the plasma increased along with the increased doses. The SAR443122 amount in the plasma was similar in Japanese and Chinese participants at the same dose level.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 16
Participants are eligible to be included in the study only if all of the following criteria apply:
Age
I 01. East Asian (Chinese and Japanese) adult male participants, between 20 and 45 years of age inclusive, at the time of signing the informed consent.
Chinese or Japanese, as country of Asian origin, according to the following criteria:
• Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China.
• Japanese; born in Japan or ethnic Japanese born outside of Japan, and a descendent of 4 ethnic Japanese grandparents who were all born in Japan.
Type of participant and disease characteristics
I 02. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
I 03. Vital signs after 10 minutes resting in supine position within the following ranges:
90 mmHg < systolic blood pressure (SBP) <140 mmHg.
40 mmHg < diastolic blood pressure (DBP) <90 mmHg.
45 bpm < heart rate (HR) <100 bpm.
I 04. Standard 12-lead ECG parameters after 10 minutes resting in supine position in the following ranges; 120 ms< PR <220 ms, QRS <120 ms, QTc (Fridericia algorithm recommended) =450 ms and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
I 05. Laboratory parameters within the normal range (or defined screening threshold for the Investigator site), unless the Investigator considers an abnormality to be clinically irrelevant for healthy participant; however hemoglobin, serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, ALT), should not exceed the upper laboratory norm. Total bilirubin out of normal range can be acceptable if total bilirubin does not exceed 1.5 the ULN with normal conjugated bilirubin values.
Weight
I 06. Body weight within the range from 50 to 100 kg and body mass index (BMI) within the range from 18 to 29.9 kg/m2 (inclusive).
Sex, contraceptive/barrier method and pregnancy testing requirements
I 07. Male
Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 74 days after the last administration of study intervention:
• Refrain from donating or cryopreserving sperm.
PLUS, either:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle
(abstinent on a long term and persistent basis) and agree to remain abstinent.
OR
- Must agree to use contraception/barrier as detailed below:
- A male condom and an additional highly effective contraceptive method as
described in Appendix 4 Contraceptive and barrier guidance when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant.
Informed Consent
I 08. Capable of giving signed informed consent as described in Appendix 1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Participants are excluded from the study if any of the following criteria apply:
Medical conditions
E 01. Any history or presence of clinically relevant immunologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
E 02. Active infection.
E 03. Blood donation, any volume, within 2 months before inclusion.
E 04. Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
E 05. Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in SBP =30 mmHg within 3 minutes when changing from supine to standing position.
E 06. Presence or history of drug hypersensitivity or allergic disease diagnosed and treated by a physician. Participants with a history of mild seasonal allergies may be included at the Investigator’s discretion.
E 07. History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
E 08. Smoking regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled).
E 09. Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
Prior/concomitant therapy
E 10. Any medication, with the exception of hormonal contraception, within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, whichever is longer, any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
Prior/concurrent clinical study experience
E 11. During the 6 months prior to the time of first IMP administration, any participant enrolled or having participated, in this or any other clinical study involving an IMP or in any other type of medical research and is still actively participating in that study.
E 12. Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
E 13. Positive alcohol breathing test.
E 14. Positive Covid-19 polymerase chain reaction (PCR) test at screening.
Diagnostic assessments
E 15. Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab), and rapid plasma reagin (RPR) for syphilis
Other exclusions
E 16. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
E 17. Participant not suitable for participation, whatever the reason, as judged by the
Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
E 18. Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with Section 1.61 of the ICH-GCP Ordinance E6).
E 19. Sensitivity or history of hypersensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates particip
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PK parameters: Cmax, AUClast, AUC
- Secondary Outcome Measures
Name Time Method Assessment of adverse events (AE)/treatment-emergent adverse events (TEAE), clinical laboratory evaluations, vital signs