A Study of RO4995819 to Assess Bioavailability and Safety in Healthy Volunteers

A Randomized, Single Dose, Open-label, Two Parts, Two and Three Period Cross-over Study to Investigate the Relative Bioavailability of Two Tablet Formulations and the Effect of Fasting Following Oral Administration of RO4995819 in Healthy Subjects

This randomized, open-label, cross-over study will assess the bioavailability and safety of RO4995819 in healthy volunteers. Volunteers will receive two different formulations (tablet and capsule) of the study drug under fed and fasting conditions.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO4995819; Drug: RO4995819

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35042

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy non-smoking male and female volunteers, 18 to 65 years of age, inclusive.
• A body mass index (BMI) between 18 to 30 kg/m2, inclusive.
• Able to participate and willing to give written informed consent and to comply with the study restrictions.
• Willing not to participate in any other clinical trial with an investigational drug or device for at least 3 months following the follow up visit.
• Male volunteers and their partners of childbearing potential must use two adequate methods of contraception. Female volunteers who are not either surgically sterile or postmenopausal must commit to use two adequate methods of contraception throughout the study and until at least 5 months after last dosing.

Exclusion Criteria:

• History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder or cancer
• Significant past or present disorders of the central nervous system, psychiatric disorders, behavioral disturbances
• Diseases or medical conditions that are capable of altering the absorption, metabolism or elimination of drugs
• Any condition or disease detected during the medical interview / physical examination that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study in the opinion of the Investigator
• Clinically significant abnormalities in laboratory test results
• Confirmed resting pulse rate greater than 90 or less than 40 beats per minute (bpm) at screening
• Confirmed systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg at screening
• Any major illness within the 4 weeks prior to dosing or any acute disease state within 7 days of study start
• Any confirmed allergic reaction against any drug or multiple allergies
• Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
• Infection with hepatitis B, hepatitis C virus, or HIV 1 and HIV 2

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RO4995819 capsule	Drug: RO4995819; Oral doses of RO4995819 (tablet); Drug: RO4995819; Oral doses of RO4995819 (capsule)
EXPERIMENTAL: RO4995819 tablet	Drug: RO4995819; Oral doses of RO4995819 (tablet); Drug: RO4995819; Oral doses of RO4995819 (capsule)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioavailability: Plasma concentration of RO4995819	Approximately 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: incidence of adverse events	Approximately 3 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: July 3, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (ESTIMATE): July 17, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BP28433; 2012-002710-39 (EUDRACT_NUMBER)