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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01665976
First received: August 14, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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 i n the fasted or fed condition, or RO4917838 hard gelatin capsules or RO4917838 o ral suspension, with a washout period of at least 21 days between treatments. An ticipated time on study will be up to 23 weeks.


Condition Intervention Phase
Healthy Volunteer
Drug: RO4917838
Drug: RO4927838
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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) [ Time Frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12 ] [ Designated as safety issue: No ]
  • Relative bioavailability of single dose RO4917838 hard gelatin capsules as compared to FCT: Area under the concentration-time curve [ Time Frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12 ] [ Designated as safety issue: No ]
  • Relative bioavailability of single dose RO4917838 oral suspension as compared to FCT [ Time Frame: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 h post-dose, and up to Day 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 months ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: August 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: film coated tablets, fasted condition Drug: RO4917838
film coated tablet, single dose
Experimental: B: film coated tablets, fed condition Drug: RO4917838
film coated tablet, single dose
Experimental: C: hard gelatin capsules Drug: RO4927838
hard gelatin capsule, single dose
Experimental: D: oral suspension Drug: RO4917838
oral suspension, single dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665976

Locations
France
Rueil-Malmaison, France, 92502
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01665976     History of Changes
Other Study ID Numbers: BP25593, 2012-000739-13
Study First Received: August 14, 2012
Last Updated: July 7, 2014
Health Authority: France: ANSM - Agence Nationale de Sécurité du Médicament

ClinicalTrials.gov processed this record on July 26, 2014