A Fixed-Sequence, Drug-Drug Interaction Study Between Multiple Oral Doses of Inarigivir Soproxil and a Single Oral Dose of Midazolam in Healthy Subjects
Condition: Drug Interaction Potentiation
Intervention: Midazolam; Inarigivir
Intervention description: Midazolam; Inarigivir
Intervention MeSH terms: Midazolam
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a single center, open-label, fixed sequence study to investigate the effect of
      multiple oral dosing of Inarigivir Soproxil and a single oral dose of Midazolam in Healthy
      Subjects
    

Eligibility criteria:

        Inclusion Criteria:

          1. Gender : male or female

          2. Age : 18-55 years, inclusive, at screening

          3. Body mass index (BMI) : 18.0-30.0 kg/m2, inclusive, at screening

          4. Status : healthy subjects

          5. At screening, females must be non-pregnant and non-lactating, or of non-childbearing
             potential (either surgically sterilized or physiologically incapable of becoming
             pregnant, or at least 1 year post-menopausal [amenorrhoea duration of 12 consecutive
             months]); non-pregnancy will be confirmed for all females by a serum pregnancy test
             conducted at screening, and a urine pregnancy test at each admission and at follow-up

          6. Female subjects of childbearing potential, with a fertile male sexual partner, must
             agree to use adequate contraception from screening until 90 days after the follow-up
             visit. Adequate contraception is defined as using a non-hormonal intrauterine device
             combined with at least 1 of the following forms of contraception: a diaphragm or
             cervical cap, or a condom; please note that hormonal contraceptives are not allowed.
             Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable

          7. Male subjects, if not surgically sterilized, must agree to use adequate contraception
             and not donate sperm from admission to the clinical research center until 90 days
             after the follow-up visit. Adequate contraception for the male subject (and his female
             partner) is defined as using hormonal contraceptives or an intrauterine device,
             combined with at least 1 of the following forms of contraception: a diaphragm or
             cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of
             the subject is acceptable

          8. All prescribed medication, including hormonal contraceptives for female subjects, must
             have been stopped at least 30 days prior to admission to the clinical research center

          9. All over-the-counter medication, vitamin preparations and other food supplements, or
             herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior
             to admission to the clinical research center. An exception is made for paracetamol,
             which is allowed up to admission to the clinical research center

         10. Ability and willingness to abstain from alcohol, methylxanthine-containing beverages
             or food (coffee, tea, cola, chocolate, energy drinks) and grapefruit (juice) from 72
             hours prior to admission to the clinical research center

         11. Good physical and mental health on the basis of medical history, physical examination,
             clinical laboratory, electrocardiogram (ECG) and vital signs, as judged by the PI

         12. Willing and able to sign the ICF

        Exclusion Criteria:

          1. Employee of PRA or the Sponsor

          2. History of relevant drug and/or food allergies

          3. Using tobacco products within 60 days prior to the first drug administration

          4. History of alcohol abuse or drug addiction (including soft drugs like cannabis
             products)

          5. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including
             ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and
             alcohol) at screening and admission to the clinical research center

          6. Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals
             approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)

          7. Positive screen for hepatitis B surface antigen (HBsAg), anti-HCV antibodies or
             anti-human immunodeficiency virus (HIV) 1 and 2 antibodies

          8. Participation in a drug study within 60 days prior to the first drug administration in
             the current study. Participation in more than 4 other drug studies in the 12 months
             prior to the first drug administration in the current study

          9. Donation or loss of more than 100 mL of blood within 60 days prior to the first drug
             administration. Donation or loss of more than 1.5 liters of blood (for male subjects)
             / more than 1.0 liters of blood (for female subjects) in the 10 months prior to the
             first drug administration in the current study

         10. Significant and/or acute illness within 5 days prior to the first drug administration
             that may impact safety assessments, in the opinion of the PI