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

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO5508887; Drug: RO5508887; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67064

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 2	Drug: RO5508887; Single ascending doses; Drug: RO5508887; Single doses
Experimental: Part 1a	Drug: RO5508887; Single ascending doses; Drug: RO5508887; Single doses
Placebo Comparator: Part 1b	Drug: Placebo; Single ascending doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety/tolerability: Incidence of adverse events	up to approximately 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics: Plasma concentrations of RO5508887	predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose
Pharmacodynamics: Urine levels of RO5508887	predose to 72 hours post-dose
Pharmacodynamics: Plasma levels of markers of amyloid deposition (Abeta1-40/Abeta1-42)	predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose
Effect of food on pharmacokinetics (plasma concentrations) of a single dose of RO5508887	predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 36, 48, 60, 72 hours post-dose

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: October 26, 2011
• First Posted (Estimate): October 28, 2011

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: WP25752; 2011-002053-54 (EudraCT Number)