A Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 2/17/2019 |
Start Date: | November 7, 2018 |
End Date: | December 17, 2018 |
An Open-Label, Fixed Sequence, Two-Period Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers
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 clinical benefit
to this study. The total duration of the study for each participant is approximately 12
weeks.
cholesterol-lowering drug, pitavastatin, in healthy volunteers. There is no clinical benefit
to this study. The total duration of the study for each participant is approximately 12
weeks.
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
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