- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01911611
A Study of RO6870868 in Healthy Volunteers
July 25, 2018 updated by: Hoffmann-La Roche
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Zuidlaren, Netherlands, 9471 GP
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Single ascending doses
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Experimental: RO6870868
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Single ascending doses
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: Incidence of adverse events
Time Frame: up to 44 days
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up to 44 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time Frame: Pre-dose and up to 48 hours post-dose
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Pre-dose and up to 48 hours post-dose
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Pharmacokinetics: Maximum plasma concentration (Cmax)
Time Frame: Pre-dose and up to 48 hours post-dose
|
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
|
Pre-dose and up to 48 hours post-dose
|
Pharmacodynamics: Cytokines/neopterin levels
Time Frame: Pre-dose and up to 48 hours post-dose
|
Pre-dose and up to 48 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
July 26, 2013
First Submitted That Met QC Criteria
July 29, 2013
First Posted (Estimate)
July 30, 2013
Study Record Updates
Last Update Posted (Actual)
July 26, 2018
Last Update Submitted That Met QC Criteria
July 25, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- NP28628
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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