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

Hoffmann-La Roche0 sites60 target enrollmentAugust 2013

ConditionsHealthy Volunteer

Interventionsplacebo RO6870868

DrugsRO6870868 placebo

Overview

Phase: Phase 1
Intervention: placebo
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 60
Primary Endpoint: Safety: Incidence of adverse events
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

March 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Placebo

Intervention: placebo

RO6870868

Intervention: RO6870868

Outcomes

Primary Outcomes

Safety: Incidence of adverse events

Time Frame: up to 44 days

Secondary Outcomes

Pharmacokinetics: Area under the concentration-time curve (AUC)(Pre-dose and up to 48 hours post-dose)
Pharmacokinetics: Maximum plasma concentration (Cmax)(Pre-dose and up to 48 hours post-dose)
Effect of food on pharmacokinetics: Area under the concentration-time curve (AUC)(Pre-dose and up to 48 hours post-dose)
Pharmacodynamics: Cytokines/neopterin levels(Pre-dose and up to 48 hours post-dose)