A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01461967
First received: October 24, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This randomized, double-blind, placebo-controlled, cross-over study will assess the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunt eers. In Part 1, subjects will be randomized to receive single ascending doses o f either RO5508887 or placebo. In Part 2, subjects will receive a single dose of RO5508887 on two occasions, with or without food. Anticipated time on study is up to 12 weeks.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Single-Center, Randomized, Double-Blind, Single and Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food) and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety/tolerability: Incidence of adverse events [ Time Frame: up to approximately 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics: Plasma concentrations of RO5508887 [ Time Frame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Urine levels of RO5508887 [ Time Frame: predose to 72 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Plasma levels of markers of amyloid deposition (Abeta1-40/Abeta1-42) [ Time Frame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose ] [ Designated as safety issue: No ]
  • Effect of food on pharmacokinetics (plasma concentrations) of a single dose of RO5508887 [ Time Frame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 36, 48, 60, 72 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1a Drug: RO5508887
Single ascending doses
Placebo Comparator: Part 1b Drug: Placebo
Single ascending doses
Experimental: Part 2 Drug: RO5508887
Single doses

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers, 18-45 (Part 1) or 18-65 (Part 2) years of age inclusive; healthy status is defined by absence of evidence of any active or chronic disease
  • Body Mass Index (BMI) 18 to 30 kg/m2 inclusive
  • Male subjects must use a barrier method of contraception for the duration of the study and for 30 days after the last dose

Exclusion Criteria:

  • Suspicion of regular consumption of drugs of abuse
  • Regular smoker (>5 cigarettes, >1 pipeful or >1 cigar per day)
  • Positive for hepatitis B, hepatitis C or HIV infection
  • History of hypersensitivity or severe drug reaction
  • Participation in an investigational drug or device study within three months before the first drug administration
  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: NCT01461967

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: NCT01461967     History of Changes
Other Study ID Numbers: WP25752, 2011-002053-54
Study First Received: October 24, 2011
Last Updated: July 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on August 01, 2014