Zuidlaren, 9471 GP, Netherlands
NCT Number: NCT01911611
A Study of RO6870868 in Healthy Volunteers
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
RO6870868
DrugSingle ascending doses
Placebo
DrugSingle ascending doses
Primary outcomes
-
Safety: Incidence of adverse events
Time frame: up to 44 days
Secondary outcomes
-
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 48 hours post-dose
-
Pharmacokinetics: Maximum plasma concentration (Cmax)
Time frame: Pre-dose and up to 48 hours post-dose
-
Effect of food on pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 48 hours post-dose
-
Pharmacodynamics: Cytokines/neopterin levels
Time frame: Pre-dose and up to 48 hours post-dose
Sponsors and collaborators
Lead sponsor
Hoffmann-La Roche
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jul 30, 2013
- Registry last updated
- Jul 26, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
A Phase 1 Study to Assess the Effect of ABBV-722 on Ethinyl Estradiol and Levonorgestrel Drug Levels in Healthy Adult Female Participants
NCT07502417
Healthy Volunteer
Grayslake, Illinois, United States
View Trial DetailsLinks Between Inflammation and Cardiometabolic Diseases
NCT01934660
Cardiovascular Disease, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial DetailsA Single and Multiple Ascending Doses, Relative Bioavailability, Food Effect, and Drug-Drug Interaction Study of NX-5948 in Healthy Volunteers
NCT06717269
Healthy Volunteer
Lincoln, Nebraska, United States
View Trial DetailsDiagnosis and History Study of Patients With Different Neurological Conditions
NCT00001367
Healthy Volunteer, Nervous System Disease
Bethesda, Maryland, United States
View Trial Details