| Eligibility |
Inclusion Criteria: -Male and/or female participant, between 18 and 45 years of age,
inclusive.
- Body mass index between 18.0 and 30.0 kg/m2, inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history
and complete physical examination).
- Vital signs after 10 minutes resting in supine position within the following ranges:
- 95 mmHg < systolic blood pressure (SBP) <140 mmHg
- 50 mmHg < diastolic blood pressure (DBP) <90 mmHg
- 50 bpm < heart rate (HR) <100 bpm
- Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine
position in the following ranges; 120 ms < PR <220 ms, QRS <120 ms, QTc =450 ms
(Fridericia algorithm recommended), 50 bpm < HR <100 bpm and normal ECG tracing unless
the Investigator considers an ECG tracing abnormality to be not clinically relevant.
- 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.
- Having given written informed consent prior to undertaking any study-related
procedure.
- Covered by a health insurance system where applicable, and/or in compliance with the
recommendations of the national laws in force relating to biomedical research.
- Not under any administrative or legal supervision or under institutionalization due to
regulatory or juridical order.
- Contraceptive use by men or women should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
- Men or women of childbearing potential (WOCBP as defined by the protocol) are required
to either practice true abstinence consistent with their preferred and usual
lifestyle, or use double contraceptive methods for the entire duration of the
treatment until 6 weeks after the last treatment with venglustat for women and until
90 days for men. "Double-contraceptive methods" means:
- A barrier method such as a condom or occlusive cap (diaphragm or cervical/vault cap)
with spermicidal foam/gel/film/cream/suppository, and,
- An established non-barrier method, such as oral, injected, or implanted hormonal
methods, an intrauterine device, or an intrauterine system.
- In addition, male participants must refrain from donating sperm from the inclusion up
to 3 months after the last dosing.
- Male participants with a pregnant or breastfeeding partner must agree to remain
abstinent from penile vaginal intercourse or use a male condom during each episode of
penile penetration from the inclusion up to 3 months after the last dosing. 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,
osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or
infectious disease, or signs of acute illness.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting
only: more than twice a month).
- Blood donation, any volume, within 2 months before inclusion.
- Presence or history of clinically significant drug hypersensitivity, or allergic
disease diagnosed and treated by a physician.
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per
day on a regular basis). Note that 12 fluid ounces of regular beer, 5 fluid ounces of
wine, and 1.5 fluid ounces of distilled spirits each contain approximately 14 g of
alcohol.
- Smoking regularly more than approximately 5 cigarettes or equivalent per week, unable
to stop smoking during the study (occasional smoker can be enrolled). Excessive
consumption of beverages containing xanthine bases (more than 4 cups or glasses per
day).
- If female, pregnancy (defined as positive ß-HCG test) or breast-feeding.
- Any medication (including St John's Wort) within 14 days before inclusion or within 5
times the elimination half-life or pharmacodynamic half-life of the medication, with
the exception of hormonal contraception or menopausal hormone replacement therapy; any
vaccination within the last 28 days and any biologics (antibody or its derivatives)
given within 4 months before inclusion. Any drug which could impact by any mechanism
of action, the pharmacokinetics of the investigational medicinal product, including
moderate and strong CYP3A4 inhibitors or inducers.
- Any participant who, in the judgment of the Investigator, is likely to be noncompliant
during the study, or unable to cooperate because of a language problem or poor mental
development.
- Any participant enrolled or having participated, in any other clinical study involving
an investigational medicinal product or in any other type of medical research, and is
still in the exclusion period according to applicable regulations.
- Any participant who cannot be contacted in case of emergency.
- Any participant who is the Investigator or any subinvestigator, research assistant,
pharmacist, study coordinator, or other staff thereof, directly involved in conducting
the study, or any person dependent (employees or immediate family members) on the
study site, the Investigator or the Sponsor.
- Prisoners or participant who are legally institutionalized.
- 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-HIV-1 and anti HIV-2 Ab).
- Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates,
benzodiazepines, cannabinoids, cocaine, opiates).
- Positive alcohol test.
- Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 5
days before inclusion.
- Any participant who cannot comply with the following study restrictions: refraining
from drinking alcohol, tea, coffee, chocolate, quinine, or caffeine-containing
beverages from 1 day before institutionalization and throughout the study duration;
not smoking or using tobacco from 1 day prior to institutionalization throughout the
study duration until the end-of-study visit; following a stable lifestyle with no
intensive physical activity from 1 day prior to institutionalization throughout the
study duration until the end-of-study visit.
- Lack of sufficiently healthy dentition for chewing a hard tablet.
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