NCT01664143

Brief Summary

This single-center, randomized, double-blind, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers will receive multiple-ascending doses of RO5508887 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
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2012

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, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

August 8, 2012

Last Update Submit

November 1, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Safety: incidence of adverse events

    30 days

Secondary Outcomes (5)

  • Correlation of the age on pharmacokinetics of RO5508887

    30 days

  • Correlation of the age on pharmacodynamics of RO5508887

    30 days

  • Pharmacokinetics: plasma levels of RO5508887

    Predose and up to 144 hours post last dose, and at follow-up

  • Pharmacodynamics: Plasma levels of amyloid deposition markers

    Predose and up to 144 hours post last dose

  • Correlation of the age on safety of RO5508887

    30 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

RO5508887

EXPERIMENTAL
Drug: RO5508887

Interventions

PlaceboDRUG

Multiple doses of placebo

Placebo
RO5508887DRUG

Multiple doses of RO5508887

RO5508887

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult healthy volunteers, \>/=18 years of age
  • Body mass index (BMI) between 18 and 30 kg/m2 inclusive
  • Use of adequate contraception methods or surgically sterile

You may not qualify if:

  • Evidence of active or chronic disease
  • Regular consumption of drugs of abuse
  • Regular smoker (\>5 cigarettes per day)
  • Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
  • History of significant allergic reactions
  • Abnormal blood pressure
  • Clinical significant abnormalities (e.g., cardiovascular, laboratory values)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Strasbourg, 67064, France

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
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 14, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

FR(1)