Clinical trial NCT01665976: A Study of the Relative Bioavailability of Single Dose RO4917838 and the Effect of Food in Healthy Volunteers
Official title: A Single Center, Randomized, Single Dose, Open-label, Four Period Cross-over Study to Investigate the Relative Bioavailability of RO4917838 and the Effect of Food Following Oral Administration in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-16
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Effect of high fat and high caloric food on the relative bioavailability of single dose RO4917838 film coated tablets (FCT): Area under the concentration-time curve (AUC)
timeFrame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
measure: Relative bioavailability of single dose RO4917838 hard gelatin capsules as compared to FCT: Area under the concentration-time curve
timeFrame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
measure: Relative bioavailability of single dose RO4917838 oral suspension as compared to FCT
timeFrame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 2 months
Other outcomes:
Locations:
city: Rueil-Malmaison
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: