A Study of RO4995819 in Healthy Elderly Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of RO4995819 Following Oral Administration in Healthy Elderly Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457664
• Other study ID #: BP25589
• Status: Completed
• Phase: Phase 1
• First received: October 17, 2011
• Last updated: November 1, 2016
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety, tolerability and pharmacokinetics of RO4995819 in healthy elderly volunteers. Volunteers will be randomized to receive once daily doses of RO4995819 or matching placebo. The anticipated time on study treatment is 14 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• Adult healthy volunteer, 65-85 years of age

• Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive and a total body weight >50 kg (110 lbs)

• Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion Criteria:

• Any history or suspicion of drug or alcohol abuse

• Clinically significant or unstable cardiovascular or bronchopulmonary diseases, or any type of cancer

• History of liver disease

• Significant past or present neurological disorder

• History of psychiatric disorders

• Participation in an investigational drug or device study within 12 weeks prior to screening

• Donation of blood over 500 mL within three months prior to screening

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Placebo
Placebo to RO4995819 once daily for 14 days
• RO4995819
RO4995819 doses once daily for 14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (incidence of adverse events)		8 weeks	No
Secondary	Pharmacokinetics: area under the concentration time curve (AUC)		Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 22, 20, 36, 62	No