A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5545965 in Healthy Volunteers

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: placebo

Drug: RO5545965

Study type

Interventional

Funder types

Industry

Identifiers

NCT01864226

BP28845

Details and patient eligibility

About

This single-center, randomized, investigator/subject-blind, adaptive multiple ascending-dose, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5545965 in healthy volunteers. Subjects will be randomized to receive either RO5545965 or matching placebo daily for 12 days.

Enrollment

44 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adult male and female volunteers, 18 - 64 years of age, inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
Body mass index (BMI) 18 to 30 kg/m2 inclusive
Female subject must be post-menopausal or surgically sterile
Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for at least 30 days after the last dose of study drug

Exclusion criteria

History of any clinically significant disease or disorder
Concomitant disease or condition that could interfere with, or the treatment of which 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
Clinically significant abnormalities in laboratory test results
Suspicion of regular consumption of drug of abuse
Positive for hepatitis B, hepatitis C or HIV infection
Participation in an investigational drug or device study within 90 days prior to screening
Regular smoker (>5 cigarettes, >1 pipeful or >1 cigar per day)
History of clinically significant hypersensitivity or allergic drug reactions