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

NCT01901159 | Completed Phase 1

• 2 other identifiers: BP284332012-002710-39
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Bioavailability: Plasma concentration of RO4995819

  Approximately 3 months

Secondary Outcomes (1)

• Safety: incidence of adverse events

  Approximately 3 months

Study Arms (2)

RO4995819 capsule

EXPERIMENTAL

Drug: RO4995819

RO4995819 tablet

EXPERIMENTAL

Drug: RO4995819

Interventions

RO4995819 DRUG

Oral doses of RO4995819 (tablet)

RO4995819 tablet

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Rennes, 35042, 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: July 3, 2013
• First Posted: July 17, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (1)