A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Intervention: Balovaptan; Esomeprazole
Intervention description: Balovaptan will be administered after a high-fat, high-calorie meal (Treatment A), after a 10-hour fast (Treatment B), and after a 10-hour fast with esomeprazole 40 mg (Treatment C); Esomeprazole will be administered once daily for 6 days and with a single dose of balovaptan 1 hour after the fifth esomeprazole dose
Intervention MeSH terms: Balovaptan; Esomeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will investigate the effect of food and the effect of esomeprazole on the
      pharmacokinetics (PK) of a single dose of balovaptan in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No evidence of any active or chronic disease

          -  Body mass index (BMI) between 18 and 32 kg/m2 inclusive, at screening

          -  For women of childbearing potential: if engaging in heterosexual activity, agreement
             to use at least two adequate forms of contraception during the entire study and for 90
             days following the last dose of study drug

          -  For men: agreement to use contraceptive measures, and agreement to refrain from
             donating sperm

        Exclusion Criteria:

          -  Pregnancy or lactation (positive serum pregnancy test at screening or at admission)

          -  Any condition or disease detected during the medical interview/physical examination
             that would render the subject unsuitable for the study, place the subject at undue
             risk or interfere with the ability of the subject to complete the study in the opinion
             of the Investigator

          -  In the opinion of the Investigator, any major illness within 4 weeks prior to the
             screening examination or any febrile illness within 1 week prior to screening.

          -  History of any clinically significant, as determined by the investigator,
             gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric,
             cardiovascular, endocrinological, hematological, lymphatic, musculoskeletal,
             genitourinary, immunological, dermatological, or connective tissue or allergic
             disease, metabolic disorder, or cancer

          -  Signs and symptoms potentially indicative of peripheral neuropathy

          -  History or evidence of any medical condition potentially altering the absorption,
             distribution, metabolism, or elimination of drugs

          -  A history of clinically significant in the opinion of the Investigator
             hypersensitivity

          -  History or presence of clinically significant ECG abnormalities before study drug
             administration

          -  Clinically significant abnormalities in laboratory test results

          -  History of coagulopathies, bleeding disorders, or blood dyscrasias

          -  Current suicidal risk, in the opinion of the Investigator

          -  Unexplained syncope during the 6 months prior to screening or with presyncopal and/or
             syncopal symptoms during orthostatic challenge testing

          -  Current smoker or user of tobacco or nicotine-containing products or subjects who have
             smoked or used tobacco or nicotine-containing products within 3 months prior to first
             study drug administration

          -  Suspicion of or presence of a clinically relevant history of or current alcohol and/or
             other substance abuse or addiction.

          -  Alcohol consumption of >14 units per week for males and females

          -  Positive urine alcohol test or urine drug screen at screening or Day -1 of any
             treatment period

          -  Hormone replacement therapy if postmenopausal status cannot be ascertained from
             medical history or FSH levels

          -  Clinically relevant deviation from normal in the physical examination including vital
             signs, as determined by the investigator

          -  Positive result for HIV 1, HIV 2, hepatitis C virus antibody, or hepatitis B core
             (HBc) antibody.

          -  Participation in an investigational drug or device study within 4 weeks or 5 times the
             elimination half-life, whichever is longer, prior to first dosing, or within 5 months
             prior to first administration of study drug in case of a study with a biological, as
             calculated from the day of Follow-up visit from the previous study

          -  Donation of blood or plasma or significant blood loss within 3 months prior to
             screening

          -  Dietary restrictions that would prohibit the consumption of standardized meals or the
             highfat, high-calorie meal planned for this study

          -  Use of any prohibited medications or food before study start or subjects who do not
             agree to refrain from consuming prohibited medications or food during the study

          -  Conditions requiring concomitant medication during the study (including for dental
             conditions).

          -  Any prescribed systemic or topical medication within 4 weeks (or within 5 times the
             elimination half-life of the medication, whichever is longer) of the first
             administration of study drug

          -  Used any nonprescribed systemic or topical medication or herbal remedies within 7 days
             before the first study drug administration

          -  Received any medications known to chronically alter drug absorption or elimination
             processes within 4 weeks before the first administration of study drug

          -  Use of any drugs or substances, including herbal treatments such as St John's wort,
             that are known to be substrates, inducers, or inhibitors of CYP3A4 within 4 weeks
             before the first administration of study drug

          -  Use of any drugs or substances, including herbal treatments, such as fluoxetine,
             fluvoxamine, aspirin, norethisterone, rifampicin, etc that are known to be substrates,
             inducers, or inhibitors of CYP2C19 within 4 weeks before the first administration of
             study drug

          -  Subjects under judicial supervision, guardianship, or curatorship

          -  Poor venous access for blood sampling

          -  Participants who are intolerant to sucrose

          -  Previous exposure to balovaptan