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Clinical Trials/NCT01461967
NCT01461967CompletedPhase 1

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 enrollmentStarted: September 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
49
Primary Endpoint
Safety/tolerability: Incidence of adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Part 1a

Experimental

Intervention: RO5508887 (Drug)

Part 1b

Placebo Comparator

Intervention: Placebo (Drug)

Part 2

Experimental

Intervention: RO5508887 (Drug)

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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