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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01461967

Enrollment

Registered

2011-10-28

Start date

2011-09-30

Completion date

2011-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGPlacebo

Single ascending doses

DRUGRO5508887

Single ascending doses

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026