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

NCT01461967 | Completed Phase 1

• 2 other identifiers: WP257522011-002053-54
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Safety/tolerability: Incidence of adverse events

  up to approximately 8 weeks

Secondary Outcomes (4)

• 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

Study Arms (3)

Part 1a

EXPERIMENTAL

Drug: RO5508887

Part 1b

PLACEBO COMPARATOR

Drug: Placebo

Part 2

EXPERIMENTAL

Drug: RO5508887

Interventions

Placebo DRUG

Single ascending doses

Part 1b

RO5508887 DRUG

Single ascending doses

Part 1a

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Strasbourg, 67064, France

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 28, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (1)