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Completed

NCT Number: NCT01664143

A Single-Center Study of RO5508887 in Healthy Volunteers

This single-center, randomized, double-blind, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. Volunteers will receive multiple-ascending doses of RO5508887 or matching placebo. The anticipated time on study treatment is 14 days.

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Key information

Conditions

Healthy Volunteer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Strasbourg, 67064, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult healthy volunteers, >/=18 years of age
  • Body mass index (BMI) between 18 and 30 kg/m2 inclusive
  • Use of adequate contraception methods or surgically sterile

Exclusion criteria

  • Evidence of active or chronic disease
  • Regular consumption of drugs of abuse
  • Regular smoker (>5 cigarettes per day)
  • Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
  • History of significant allergic reactions
  • Abnormal blood pressure
  • Clinical significant abnormalities (e.g., cardiovascular, laboratory values)

Treatment and study plan

Placebo

Drug

Multiple doses of placebo

RO5508887

Drug

Multiple doses of RO5508887

Primary outcomes

  1. Safety: incidence of adverse events

    Time frame: 30 days

Secondary outcomes

  1. Correlation of the age on pharmacokinetics of RO5508887

    Time frame: 30 days

  2. Correlation of the age on pharmacodynamics of RO5508887

    Time frame: 30 days

  3. Pharmacokinetics: plasma levels of RO5508887

    Time frame: Predose and up to 144 hours post last dose, and at follow-up

  4. Pharmacodynamics: Plasma levels of amyloid deposition markers

    Time frame: Predose and up to 144 hours post last dose

  5. Correlation of the age on safety of RO5508887

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single-Center, Randomized, Investigator/Subject-Blind, Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 14, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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