A Single-Center Study of RO5508887 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01664143
First received: August 8, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Healthy Volunteer
Drug: RO5508887
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: incidence of adverse events [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of the age on pharmacokinetics of RO5508887 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Correlation of the age on pharmacodynamics of RO5508887 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics: plasma levels of RO5508887 [ Time Frame: Predose and up to 144 hours post last dose, and at follow-up ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Plasma levels of amyloid deposition markers [ Time Frame: Predose and up to 144 hours post last dose ] [ Designated as safety issue: No ]
  • Correlation of the age on safety of RO5508887 [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: July 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RO5508887 Drug: RO5508887
Multiple doses of RO5508887
Placebo Comparator: Placebo Drug: Placebo
Multiple doses of placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664143

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01664143     History of Changes
Other Study ID Numbers: WP28102, 2012-000280-24
Study First Received: August 8, 2012
Last Updated: April 7, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)

ClinicalTrials.gov processed this record on April 17, 2014