A Study of RO6870868 in Healthy Volunteers

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: RO6870868

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01911611

NP28628

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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) </= 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
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