Safety, Tolerability, Pharmacokinetics (including Food Effect) of Single Ascending Doses of SAR441121 in healthy male subjects.
A Two-part, Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of Single Ascending Doses of SAR441121 Including a Pilot Food Evaluation (TDU15302) and its Antimalarial Activity against Plasmodium falciparum Blood Stage Infection (PDY15303) in Healthy Male Subjects.
sanofi-aventis australia ptd ltd
62 participants
Oct 29, 2018
Interventional
Conditions
Summary
SAR441121 is an experimental treatment. This means that it is not an approved treatment for Malaria in Australia by the Regulatory Authority (Therapeutic Goods Administration - TGA) or any other international Regulatory Authority. The purpose of this study is to establish the safety, tolerability (how easily it is to tolerate) and pharmacokinetics (what the body does to the study drug, such as absorption, distribution and excretion) of SAR441121 in healthy male volunteers, This study also aims to investigate the effect that food may have in the safety, tolerability and pharmacokinetics of the study drug.
Eligibility
Inclusion Criteria7
- Male subjects, between 18 and 49 years of age, inclusive.
- Body weight between 50.0 and 100.0 kg, inclusive, body mass index between 18.0 and 32.0 kg/m2, inclusive.
- Normal vital signs after 5 minutes resting in supine position.
- Normal electrocardiogram parameters after 5 minutes resting in supine position.
- Laboratory parameters within the normal range unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects.
- Male subject, whose partners are of childbearing potential (including pregnant or lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom) plus (intrauterine device or hormonal contraceptive) from the inclusion up to 3 months after the last dosing.
- Male subject must agree not to donate sperm from the screening up to 3 months after the last dosing.
Exclusion Criteria10
- 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.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed by an allergist/immunologist and/or treated by a physician for allergy or history of a severe allergic reaction, anaphylaxis or convulsions following any vaccination or infusion, or subjects with a documented food allergy requiring specific medical management
- History or presence of alcohol abuse (alcohol consumption of more than 40g per day) or drug habituation, or any previous usage of an illicit substance.
- Tobacco use of more than 5 cigarettes or equivalent per day, and unable to stop smoking for the duration of the clinical unit confinement.
- Any medication (including St John’s Wort) within 14 days before consenting or within 5 times the elimination half-life or pharmacodynamic half-life of the medication except occasional intakes of ibuprofen at doses up to 1.2g/day or paracetamol at doses up to 2g/day.
- Participation in any investigational product study within the 12 weeks (counted from the last dose taken) prior to Investigational Medicinal Product (IMP) administration.
- Any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 3 months before inclusion.
- Any consumption of grapefruit and Sevilles oranges, etc or their juices within 5 days prior to Investigational Medicinal Product (IMP) administration.
- For the food effect cohort, vegetarian subjects or subjects with lactose intolerance must be excluded.
- History of serious psychiatric condition that may affect participation in the study or preclude compliance with the protocol, including but not limited to past or present psychoses, disorders requiring lithium, a history of attempted or planned suicide, more than one previous episode of major depression, any previous single episode of major depression lasting for or requiring treatment for more than 6 months, or any episode of major depression during the 5 years preceding screening.
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Interventions
There will be 5 groups each assigned to receive a different dose level of study drug or placebo. Choice of dose level(s) to be administered will be made based upon a review performed by the investigator and the sponsor representatives of the blinded safety, tolerability and pharmacokinetic data. Arm 1 - Experimental: SAR441121 - a single dose starting at 5mg under fasting conditions (overnight fasting up to 4 hours post dose) according to an ascending dose design. or SAR441121 selected single dose in fed conditions. A standardized high fat breakfast of 800 kcal will be given to the participant 30 minutes prior to study drug intake. Treatment: Drugs: SAR441121 Pharmaceutical form: Tablet Route of administration: Oral Duration: Single dose The strategies used to monitor adherence to the study drug will be: administration under direct medical supervision, mouth inspection for checking the ingestion, appropriate record of the dosing information, counts of the number of tablets.
Locations(1)
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ACTRN12618001783213