| Eligibility |
Inclusion Criteria:
1. Healthy adult male or female aged 18 to 49 years
2. Provision of written informed consent to participate as shown by a signature on the
subject consent form
3. Smoke no more than 5 cigarettes a day are permitted. Smocking (including the use of
smocking substitute e.g. nicotine patch) is not permitted from screening to the end of
study visit
4. Body weight of at least 45kg and a BMI included between 18.0 and 35.0 kg/m2
5. Female subjects of childbearing potential must use a highly effective method of
contraception to prevent pregnancy for 4 weeks before inclusion and must agree to
continue strict contraception for 30 days after last administration of IMP. Male
participants with female partners of childbearing potential must be willing to use a
condom and require their partner to use an additional form of adequate contraception
as approved by the Investigator. This requirement begins at the time of informed
consent and ends at least 3 months after the last administration of IMP. Male study
participants must also not donate sperm from baseline until 3 months after the last
administration of IMP.
6. Considered as healthy after a comprehensive clinical assessment (detailed medical
history and complete physical examination)
7. Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 minutes
in supine position.
8. Normal ECG recording on a 12-lead ECG at the screening visit:
9. Laboratory parameters within the normal range of the laboratory (hematological, blood
chemistry tests, urinalysis). Individual values out of the normal range can be
accepted if judged non-clinically significant by the Investigator
10. Has not consumed and agrees to abstain from taking any dietary supplements or
non-prescription drugs over the 7 days prior to screening.
11. Has not consumed and agrees to abstain from taking any prescription drugs except
contraception.
12. Has not consumed alcohol containing beverages over the 48 hours prior to
hospitalization
13. Has not consumed grapefruit or grapefruit juice over the 48 hours prior to
hospitalization
14. Has the ability to understand the requirements of the study and is willing to comply
with all study procedures
15. Registered with the French Social Security in agreement with the French law on
biomedical experimentation and register to the "Fichier national des personnes qui se
prêtent à des recherches biomédicales"
Exclusion Criteria:
1. Have already received setanaxib
2. Contraindication(s) for any of the substrates used in the study
3. Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic,
renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious
disease
4. Any history of severe cardiovascular disease, and any personal or family history of
long QT syndrome, or evidence of abnormalities in cardiac conduction
5. Frequent headaches and / or migraine, recurrent nausea and / or vomiting
6. Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic
postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20
mmHg within two minutes when changing from the supine to the standing position
7. Blood donation (including in the frame of a clinical study) within 2 months before
administration;
8. General anesthesia within 3 months before administration
9. Presence or history of drug hypersensitivity, or allergic disease diagnosed and
treated by a physician
10. Inability to abstain from intensive muscular effort
11. No possibility of contact in case of emergency
12. Any drug intake (except paracetamol or oral contraception) during the last month prior
to the first administration
13. History or presence of drug or alcohol abuse (alcohol consumption > 40 grams / day)
14. Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day)
during the last 30 days
15. Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody,
or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests
16. Positive results of screening for drugs of abuse
17. Any contraindication to the administration of midazolam, adefovir, losartan,
omeprazole, sitagliptin
18. Subject who, in the judgment of the Investigator, is likely to be non-compliant or
uncooperative during the study, or unable to cooperate because of a language problem,
poor mental development
19. Currently in exclusion period from a previous study
20. Administrative or legal supervision
21. Subject who would receive more than 4500 euros as indemnities for his participation in
biomedical study within the 12 last months, including the indemnities for the present
study.
22. Minor, pregnant or breast-feeding women, persons deprived of liberty by judicial or
administrative decision, persons receiving psychiatric care and persons admitted to a
health or social institution, adult subject to legal protection or unable to express
consent.
23. Positive results for SARS-CoV-2 tests.
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