A Study of RO6870868 in Healthy Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:8/3/2016
Start Date:August 2013
End Date:March 2014

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A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacodynamics and the Effect of Food on the Pharmacokinetics of RO6870868

This randomized, double-blind, placebo-controlled study will evaluate the safety,
tolerability, pharmacokinetics of RO6870868 in healthy volunteers. Subjects will be
randomized to receive single ascending doses of either RO6870868 or placebo, with or without
food.


Inclusion Criteria:

- Healthy male and female subjects, 18 to 65 years of age, inclusive. Healthy status is
defined by absence of evidence of any active or chronic disease following a detailed
medical and surgical history and a complete physical examination

- Women of non-childbearing potential including women who have undergone hysterectomy
or bilateral oophorectomy and postmenopausal females

- Male subjects must be willing to use effective contraception as defined by protocol
for the duration of the study and for one month after the last dose of study
medication

- Body Mass Index (BMI) at screening of 18 to 32 kg/m2, inclusive

- Non-smokers, or use of < 10 cigarettes (or equivalent nicotine-containing product)
per day

- No medical or social conditions that would potentially interfere with the subjects
ability to comply with the study visit schedule or the study assessments

Exclusion Criteria:

- Pregnant (positive pregnancy test) or lactating women, and male partners of women who
are pregnant or lactating

- History of drug or alcohol abuse within the last year

- History of immunologically mediated disease

- History or symptoms of any significant disease including (but not limited to)
neurological, cardiovascular, endocrine, respiratory, gastrointestinal, hepatic, or
renal disorder

- Personal or family history of congenital long QT syndrome or sudden death

- Evidence of an active or suspected cancer or a history of malignancy where in the
investigator's opinion, there is a risk of recurrence. History of having received any
systemic anti-neoplastic (including radiation) or immunomodulatory treatment
(including systemic oral or inhaled corticosteroids) dose of study drug or the expectation that such treatment will be needed at any time
during the study

- Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any
drug, or multiple drug allergies (non-active hay fever is acceptable)

- History of significant psychiatric disease

- Significant acute infection, e.g., influenza, local infection, acute gastrointestinal
symptoms or any other clinically significant illness within two weeks of dose
administration

- History of gastrointestinal disease including inflammatory bowel disease, peptic
ulcer disease, gastrointestinal hemorrhage

- Inadequate hematologic, renal or liver function

- Positive for hepatitis A, hepatitis B, hepatitis C, or HIV infection

- History (within 3 months of screening) of alcohol consumption exceeding 14 units per
week on average (1 unit = 10 grams of alcohol). Alcohol consumption will be
prohibited at least 48 hours before screening, 48 hours before admission, 48 hours
after each dose, and 48 hours before each scheduled visit

- Any clinically significant concomitant disease or condition that could interfere
with, or for which the treatment of might interfere with, the conduct of the study,
or that would, in the opinion of the investigator, pose an unacceptable risk to the
subject in this study

- Subjects who had received IFN or peginterferon within 8 weeks prior to dosing

- Participation in other clinical studies of a new chemical entity within 60 days prior
to study randomization
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