A Study of the Relative Bioavailability of Single Dose RO4917838 and the Effect of Food in Healthy Volunteers

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: RO4927838

Drug: RO4917838

Study type

Interventional

Funder types

Industry

Identifiers

NCT01665976

2012-000739-13 (EudraCT Number)

BP25593

Details and patient eligibility

About

This single center, randomized, single dose, open-label, four period cross-over study will evaluate the relative bioavailability of RO4917838 and the effect of food following oral administration in healthy volunteers. Subjects will receive in randomized order single oral doses of RO4917838 film coated tablets, either in the fasted or fed condition, or RO4917838 hard gelatin capsules or RO4917838 oral suspension, with a washout period of at least 21 days between treatments. Anticipated time on study will be up to 23 weeks.

Enrollment

16 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male and female volunteers, 18 to 65 years of age, inclusive
Body mass index (BMI) 18 to 30 kg/m2 inclusive
Healthy as determined by the Investigator on the basis of medical and surgical history and a complete physical examination
Non-smoker or smoker of fewer than 10 cigarettes per day; subject must be able to refrain from smoking during the in-patient stays
Females who are not postmenopausal or surgically sterile must agree to use two adequate methods of contraception as defined by protocol during the treatment period and for at least one month after the last dose of study drug

Exclusion criteria

Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator
History of alcoholism, drug abuse and/or drug addiction within the last year prior to Period 1. Day -1 of the study
History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer
Any history of depressive episodes or treatment with antidepressants
Any significant allergic reactions against any drug, or multiple allergies in the judgement of the Investigator
Pregnant or lactating females
Positive for hepatitis B, hepatitis C or HIV infection
Participation in another investigational study of any type within 90 days of RO4917838 administration or within 6 times the elimination half-life of the tested drug, whichever is longer