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.

Hoffmann-La Roche0 sites49 target enrollmentSeptember 2011

ConditionsHealthy Volunteer

InterventionsRO5508887 Placebo

DrugsPlacebo RO5508887

Overview

Phase: Phase 1
Intervention: RO5508887
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 49
Primary Endpoint: Safety/tolerability: Incidence of adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

December 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Part 1a

Intervention: RO5508887

Part 1b

Intervention: Placebo

Part 2

Intervention: RO5508887

Outcomes

Primary Outcomes

Safety/tolerability: Incidence of adverse events

Time Frame: up to approximately 8 weeks

Secondary Outcomes

Pharmacodynamics: Urine levels of RO5508887(predose to 72 hours post-dose)
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: 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)