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

NCT01665976 | Completed Phase 1

• 2 other identifiers: BP255932012-000739-13
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

• 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)

  Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12

• Relative bioavailability of single dose RO4917838 hard gelatin capsules as compared to FCT: Area under the concentration-time curve

  Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12

• Relative bioavailability of single dose RO4917838 oral suspension as compared to FCT

  Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12

Secondary Outcomes (1)

• Safety: Incidence of adverse events

  approximately 2 months

Study Arms (4)

A: film coated tablets, fasted condition

EXPERIMENTAL

Drug: RO4917838

B: film coated tablets, fed condition

EXPERIMENTAL

Drug: RO4917838

C: hard gelatin capsules

EXPERIMENTAL

Drug: RO4927838

D: oral suspension

EXPERIMENTAL

Drug: RO4917838

Interventions

RO4917838 DRUG

film coated tablet, single dose

A: film coated tablets, fasted condition; B: film coated tablets, fed condition

RO4927838 DRUG

hard gelatin capsule, single dose

C: hard gelatin capsules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Rueil-Malmaison, 92502, France

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 16, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (1)