A Phase 1, open-label, single-center study to determine the absorption, distribution, metabolism, and excretion of a single oral dose of SAR443820 containing microtracer [14C]-SAR443820 in healthy male participants
- Trial ID
- 2022-502534-23-00
- Protocol
- BEX17501
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the **pharmacokinetics** of SAR443820 in healthy male adult participants. This involves assessing the absorption, metabolism, and excretion of the medication when administered orally in liquid form. Understanding the pharmacokinetics is clinically relevant as it provides essential information on how the body processes the drug, which is crucial for determining appropriate dosing regimens and ensuring safety and efficacy in future therapeutic applications, particularly for conditions such as **amyotrophic lateral sclerosis (ALS)**.
Participants
The clinical trial focuses on **amyotrophic lateral sclerosis (ALS)** and involves a study population exclusively composed of male participants. The age range for the participants is categorized under code "3," which typically corresponds to adults, although specific age details are not provided. The trial does not include a vulnerable population, and the selection criteria for participants have not been disclosed by the sponsor. Additionally, there is no information available regarding the total number of participants, as the sponsor has not provided this data. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits for the participants. The study population was selected based on criteria that have not been detailed in the available data.
Plans and Procedures
The clinical trial is designed to evaluate the pharmacokinetics of the investigational medicinal product SAR443820 in healthy male adults. The study is structured as a **randomized**, **double-blind**, and **controlled** trial, ensuring that neither the participants nor the researchers know who is receiving the test medicine or the placebo, thus minimizing bias. The trial is set to commence on April 18, 2023, with an estimated completion date of August 9, 2023, indicating a total duration of approximately four months.
Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit. During this visit, eligibility criteria will be assessed to ensure participants meet the necessary requirements for inclusion in the study. Following successful screening, participants will be randomized to receive either the investigational product or a placebo. Throughout the trial, there will be scheduled follow-up visits to monitor the participants' health, assess the pharmacokinetics of the drug, and ensure adherence to the study protocol. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather comprehensive data on the investigational product's effects.
The expected length of participant involvement is contingent upon the trial's timeline, with each participant expected to remain in the study for the full duration unless specific conditions necessitate early termination. Such conditions may include adverse reactions to the investigational product, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial's design and procedures are meticulously crafted to ensure the collection of reliable data while prioritizing participant safety and adherence to ethical standards.
Treatment
The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.
In this study, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. The absence of these details suggests that the focus is primarily on the experimental medication, although further clarification would be necessary to confirm this aspect of the trial design.
Due to the lack of specific information, it is not possible to provide additional relevant details about drug administration, dosing schedules, or participant compliance monitoring. The trial documentation does not include any data on the product's authorization status, pharmaceutical form, or the origin of the active substances involved in the study.
Efficacy
No specific details regarding the assessment of efficacy in the clinical trial are provided in the available data. Information on parameters or endpoints, methods, schedule for measuring, collecting, and analyzing efficacy parameters, as well as tools or instruments involved in efficacy assessments, is not included. The trial is categorized under phase 9, but further specifics on efficacy evaluation are not available.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Male participants, 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
- Vital signs after 5 minutes (at a minimum) resting in supine position within the following ranges: - 95 mmHg ≤ systolic blood pressure (SBP) <140 mmHg - 45 mmHg < diastolic blood pressure (DBP) <90 mmHg - 45 bpm < heart rate (HR) <100 bpm
- Standard 12-lead ECG parameters after 5 minutes (at a minimum) resting in supine position in the following ranges: 120 ms
- 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 participants; however, serum creatinine, alkaline phosphatase, hepatic enzymes (AST, ALT), should not exceed 1.25-fold the ULN for each.
- Body weight within 60.0 and 90.0 kg inclusive and body mass index (BMI) within the range 18.0 to <30.0 kg/m2
- Male Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a) Male participants Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last administration of study intervention: - Refrain from donating 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; the participant should also be advised of the benefit for a female partner to use a highly effective method of contraception (as described in Appendix 4 [Section 10.4] Contraceptive and barrier guidance) as a condom may break or leak when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. b) Female participants: Not applicable.
- Capable of giving signed informed consent as described in Appendix 1 (Section 10.1) of the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Normal renal function as expressed by body surface area-normalized glomerular filtration rate (GFR) >90 mL/min/1.73 m2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (9, 10).
- Must have regular bowel movements (ie, average stool production of ≥1 per 48-hour interval and ≤3 stools per day).
Exclusion Criteria
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
- Medical history of seizure (history of febrile seizure during childhood is allowed).
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- Blood donation, any volume (usually approximately 500 mL), within 3 months before inclusion (Day 1).
- Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥30 mmHg within 3 minutes when changing from supine to standing position.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. Participants with known hypersensitivity to any component of the IMP formulation or allergic disease diagnosed and treated by a physician.
- History or presence of drug or alcohol abuse (alcohol consumption more than 24 units per week on a regular basis).
- Smoking regularly more than 5 cigarettes or equivalent per day, unable to avoid smoking, tobacco, or other nicotine-containing product (such as lozenges or vaporizers) on Day -1 and Day 1. Excessive consumption of beverages containing xanthine bases (more than 6 cups or glasses per day). Intake of poppy seeds within 48 hours prior to drug screens (to avoid false-positive drug screen results).
- Any medication (including supplements or herbal medicines such as St John’s Wort) within 14 days (or 3 weeks if the concomitant drug is a potential enzyme inducer) or within 5 times the elimination half-life or pharmacodynamic half-life of the medication as far as known (whichever is longer) before inclusion (Day 1) (see Section 6.9); any non-live COVID-19 vaccine within the last 2 weeks before inclusion (Day 1), any live attenuated vaccine within the last 28 days before inclusion (Day 1), and any other non-vaccine biological drugs given within 4 months before inclusion (Day 1). Property of the Sanofi group - strictly confidential
- Past participation in previous clinical studies on SAR443820. Current enrollment OR past participation in another investigational study within 30 days prior to inclusion (or inclusion within 5 times the elimination half-life or pharmacodynamic half-life, as far as known, of the investigational drug received in another investigational study), or in 4 or more other investigational drug studies within 12 months prior to inclusion (Day 1).
- Positive result on any of the following tests: hepatitis B surface antigen (HBs Ag), anti-hepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2 Ab).
- Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Positive urine alcohol test.
- Positive SARS-CoV-2 test (measured by Real-time Reverse Transcriptase Polymerase Chain Reaction [RT-PCR]).
- Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
- 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.
- Participants who 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 International Council for Harmonisation [ICH]-Good Clinical Practice [GCP] Ordinance E6).
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
- Any country-related specific regulation that would prevent the participant from entering the study – see Appendix 8 (Section 10.8) of the protocol (country-specific requirements).
- Any consumption of citrus fruits (grapefruit, Seville orange, etc) or their juices within 5 days before inclusion (Day 1).
- Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), and/or during work, and/or during participation in a trial with [14C]-radiolabeled medication (>0.1 MBq) in the 12 months preceding the study. Participation in a previous study with a micro-tracer dose (≤0.1 MBq) in the 3 months preceding the study.
- Participants with [14C] in blood >lower limit of quantification (LLOQ) when using AMS at screening.
- Participants who do not have suitable veins for multiple venipunctures/cannulation as assessed by the Investigator or delegate at screening.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 The Netherlands | Not Recruiting | 18 Apr 2023 | — |
| Netherlands | — | — | 6 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
SAR443820 | Test | ORAL SOLUTION | ORAL USE | 0.4 | 1 | PRD10256611 |