A Study of RO4995819 in Healthy Elderly Volunteers | NCT01457664

Studies
A Study of RO4995819 in Healthy Elderly Volunteers

NCT01457664

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Healthy Volunteer

Interventions

Placebo
RO4995819

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Oct 17, 2011

First Submission Date that Met QC Criteria

Oct 20, 2011

First Posted Date

Oct 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
RO4995819	Experimental		Drug: RO4995819

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo to RO4995819 once daily for 14 days	Placebo
RO4995819

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety (incidence of adverse events)		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

85 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Miramar	Florida	33025	United States