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Completed

NCT Number: NCT01461967

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

Male

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

  • 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

Treatment and study plan

Placebo

Drug

Single ascending doses

RO5508887

Drug

Single ascending doses

Primary outcomes

  1. Safety/tolerability: Incidence of adverse events

    Time frame: up to approximately 8 weeks

Secondary outcomes

  1. Pharmacokinetics: Plasma concentrations of RO5508887

    Time frame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose

  2. Pharmacodynamics: Urine levels of RO5508887

    Time frame: predose to 72 hours post-dose

  3. Pharmacodynamics: Plasma levels of markers of amyloid deposition (Abeta1-40/Abeta1-42)

    Time frame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose

  4. Effect of food on pharmacokinetics (plasma concentrations) of a single dose of RO5508887

    Time frame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 36, 48, 60, 72 hours post-dose

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 28, 2011
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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