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A Study on Safety, Pharmacokinetics and Pharmacodynamics 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: NCT01461967
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This randomized, double-blind, placebo-controlled, cross-over study will assess the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects will be randomized to receive single ascending doses of 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 or disease Intervention/treatment Phase
Healthy Volunteer Drug: Placebo Drug: RO5508887 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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.
Study Start Date : September 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: Part 1a Drug: RO5508887
Single ascending doses

Placebo Comparator: Part 1b Drug: Placebo
Single ascending doses

Experimental: Part 2 Drug: RO5508887
Single doses

Primary Outcome Measures :
  1. Safety/tolerability: Incidence of adverse events [ Time Frame: up to approximately 8 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Pharmacodynamics: Urine levels of RO5508887 [ Time Frame: predose to 72 hours post-dose ]
  3. 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 ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

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): NCT01461967

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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: NCT01461967    
Other Study ID Numbers: WP25752
2011-002053-54 ( EudraCT Number )
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016