NCT01457664

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

October 17, 2011

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Safety (incidence of adverse events)

    8 weeks

Secondary Outcomes (1)

  • 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

RO4995819

EXPERIMENTAL
Drug: RO4995819

Interventions

PlaceboDRUG

Placebo to RO4995819 once daily for 14 days

Placebo
RO4995819DRUG

RO4995819 doses once daily for 14 days

RO4995819

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Miramar, Florida, 33025, United States

Location

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2011

First Posted

October 24, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(1)