A Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: RO7049389; Pitavastatin
Intervention description: RO7049389 will be taken orally, in tablet form, BID on Days 1-6 of Period 2.; Pitavastatin will be taken orally, in tablet form, once on Day 1 of Period 1, and once on Day 4 of Period 2.
Intervention MeSH terms: Pitavastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of the study is to characterize the interaction between RO7049389 and the
      cholesterol-lowering drug, pitavastatin, in healthy volunteers. There is no intended clinical
      benefit to this study. The total duration of the study for each participant is approximately
      12 weeks.
    

Eligibility criteria:

        Inclusion Criteria

          -  Healthy, as judged by the Investigator. Healthy status is defined by absence of
             evidence of any active or chronic disease following a detailed medical and surgical
             history, a complete physical examination including vital signs, 12-lead ECG, and based
             on the laboratory safety test results at screening and Day -1

          -  Body mass index (BMI) between 18 to 30 kg/m2 (inclusive) at screening

          -  Female participants: 1) Must be either surgically sterile (by means of hysterectomy
             and/or bilateral oophorectomy and/or bilateral salpingectomy) or post-menopausal for
             at least one year (defined as amenorrhea >/=12 consecutive months without another
             cause, and confirmed by follicle-stimulating hormone (FSH) level. 2) Participants must
             not be pregnant or lactating.

          -  Male participants: 1) Female partners must not be pregnant or lactating. 2) Must agree
             to remain abstinent (refrain from heterosexual intercourse) or must agree to use a
             condom with spermicide during the treatment period and for at least 28 days after the
             last dose of study drug with female partners of childbearing potential. 3) Must agree
             to refrain from donating sperm during the treatment period and for at least 28 days
             after the last dose of study drug

        Exclusion Criteria

          -  Have a history or symptoms of any clinically significant cardiovascular, respiratory,
             hepatic, renal, gastrointestinal, endocrine, hematological, oncologic or neurological
             disorders capable of significantly altering the absorption, metabolism, or elimination
             of drugs; of constituting a risk when taking the study treatment; or of interfering
             with the interpretation of data

          -  Confirmed (based on the average of 3 separate resting BP measurements in a supine
             position, after at least 5 minutes rest) systolic BP greater than 140 or less than 90
             mmHg, and diastolic BP greater than 90 or less than 50 mmHg at screening and Day -1

          -  Personal history or family history of congenital long QT syndrome and/or cardiac
             sudden death

          -  History of Gilbert's syndrome

          -  Participants who have had significant acute infection, e.g., influenza, local
             infection, acute gastrointestinal symptoms or any other clinically significant illness
             within two weeks of dose administration

          -  Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any
             drug, or multiple drug allergies (non-active hay fever is acceptable)

          -  Taking any herbal medications or substances (e.g., tea) or supplements (including
             vitamins), or traditional Chinese medicines (TCM) or over-the-counter (OTC)
             medications within 14 days of first dosing or within 5 times the elimination half-life
             of the medication prior to first dosing, whichever is longer

          -  History of having received any systemic anti-neoplastic (including radiation) or
             immunemodulatory treatment (including systemic oral or inhaled corticosteroids) </=6
             months prior to the first dose of study drug or the expectation that such treatment
             will be needed at any time during the study

          -  Are currently enrolled in or have participated in any other clinical study involving
             an investigational product or in any other type of medical research within the last 30
             days or 5 half lives (whichever is longer)

          -  Donation or loss of blood or blood products in excess of 500 mL within 3 months of
             screening and for the duration of the study

          -  Positive test for drugs of abuse (including recreational drugs) and/or positive
             alcohol test and/or positive cotinine test at screening and on Day -1

          -  Positive test at screening of any of the following: Hepatitis A virus (HAV IgM Ab),
             hepatitis B virus (HBsAg or HBcAb), hepatitis C virus (HCV RNA or HCV Ab) or human
             immunodeficiency virus (HIV-1 and HIV-2 Ab)

          -  History of alcohol consumption exceeding 2 standard drinks per day on average (1
             standard drink = 10 grams of alcohol) and/or drug abuse within 12 months of screening

          -  Use of >5 cigarettes or equivalent nicotine-containing product per day prior to
             screening