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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO5508887; Drug: Placebo

• Registration Number: NCT01461967
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-28
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 1a	RO5508887	-
Part 1b	Placebo	-
Part 2	RO5508887	-

Primary Outcome Measures

Name	Time	Method
Safety/tolerability: Incidence of adverse events	up to approximately 8 weeks

Secondary Outcome Measures

Name	Time	Method
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