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OpenTrials
Completed

NCT Number: NCT01457664

A Study of RO4995819 in Healthy Elderly Volunteers

This study will evaluate the safety, tolerability and pharmacokinetics of RO4995819 in healthy elderly volunteers. Volunteers will be randomized to receive once daily doses of RO4995819 or matching placebo. The anticipated time on study treatment is 14 days.

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Key information

Conditions

Healthy Volunteer

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Miramar, Florida, 33025, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult healthy volunteer, 65-85 years of age
  • Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive and a total body weight >50 kg (110 lbs)
  • Able to participate and willing to give written informed consent and to comply with the study restrictions

Exclusion criteria

  • Any history or suspicion of drug or alcohol abuse
  • Clinically significant or unstable cardiovascular or bronchopulmonary diseases, or any type of cancer
  • History of liver disease
  • Significant past or present neurological disorder
  • History of psychiatric disorders
  • Participation in an investigational drug or device study within 12 weeks prior to screening
  • Donation of blood over 500 mL within three months prior to screening

Treatment and study plan

Placebo

Drug

Placebo to RO4995819 once daily for 14 days

RO4995819

Drug

RO4995819 doses once daily for 14 days

Primary outcomes

  1. Safety (incidence of adverse events)

    Time frame: 8 weeks

Secondary outcomes

  1. Pharmacokinetics: area under the concentration time curve (AUC)

    Time frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 22, 20, 36, 62

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of RO4995819 Following Oral Administration in Healthy Elderly Subjects.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 24, 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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