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A Single-Center Study of RO5508887 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01664143
Recruitment Status : Completed
First Posted : August 14, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: Placebo Drug: RO5508887 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Single-Center, Randomized, Investigator/Subject-Blind, Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects
Study Start Date : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Multiple doses of placebo

Experimental: RO5508887 Drug: RO5508887
Multiple doses of RO5508887

Primary Outcome Measures :
  1. Safety: incidence of adverse events [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Correlation of the age on pharmacokinetics of RO5508887 [ Time Frame: 30 days ]
  2. Correlation of the age on pharmacodynamics of RO5508887 [ Time Frame: 30 days ]
  3. Pharmacokinetics: plasma levels of RO5508887 [ Time Frame: Predose and up to 144 hours post last dose, and at follow-up ]
  4. Pharmacodynamics: Plasma levels of amyloid deposition markers [ Time Frame: Predose and up to 144 hours post last dose ]
  5. Correlation of the age on safety of RO5508887 [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01664143

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Strasbourg, France, 67064
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT01664143     History of Changes
Other Study ID Numbers: WP28102
2012-000280-24 ( EudraCT Number )
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016