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

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: RO4995819

Study type

Interventional

Funder types

Industry

Identifiers

NCT01901159

BP28433

2012-002710-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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