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: August 26, 2014
Last verified: August 2014
  Purpose

This single-center, randomized, double-blind, placebo-controlled study will eval uate the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy v olunteers. Volunteers will receive multiple-ascending doses of RO5508887 or matc hing placebo. The anticipated time on study treatment is 14 days.


Condition Intervention Phase
Healthy Volunteer
Drug: Placebo
Drug: RO5508887
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
Placebo Comparator: Placebo Drug: Placebo
Multiple doses of placebo
Experimental: RO5508887 Drug: RO5508887
Multiple doses of RO5508887

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 26, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)

ClinicalTrials.gov processed this record on August 28, 2014