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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665976
• Other study ID #: BP25593
• Secondary ID: 2012-000739-13
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2012
• Last updated: November 1, 2016
• Start date: August 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: ANSM - Agence Nationale de Sécurité du Médicament
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4917838
film coated tablet, single dose
• RO4917838
oral suspension, single dose
• RO4927838
hard gelatin capsule, single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Safety: Incidence of adverse events		approximately 2 months	No