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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901159
• Other study ID #: BP28433
• Secondary ID: 2012-002710-39
• Status: Completed
• Phase: Phase 1
• First received: July 3, 2013
• Last updated: November 1, 2016
• Start date: June 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: L'Agence nationale de sécurité du médicament et des produits de santé (ANSM)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4995819
Oral doses of RO4995819 (tablet)
• RO4995819
Oral doses of RO4995819 (capsule)

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	Bioavailability: Plasma concentration of RO4995819		Approximately 3 months	No
Secondary	Safety: incidence of adverse events		Approximately 3 months	No