Skip to main content
OpenTrials
Completed

NCT Number: NCT01409369

A Study on The Effect of Multiple Doses of Activated Charcoal on The Pharmacokinetics of a Single Dose of RO4995819

This open-label, two period crossover study will evaluate the effect of multiple doses of activated charcoal on the pharmacokinetics of a single oral dose of RO4995819 in healthy volunteers. Each enrolled subject will receive two single oral doses of RO4995819 separated by a wash-out period of up to 9 weeks. In period 1, subjects will receive concomitantly with the single dose of RO4995819 multiple oral doses of activated charcoal until Day 7. In period 2, only a single dose of RO4995819 but no activated charcoal will be administered.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Rennes, 35042, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects, 18 to 65 years of age, inclusive
  • Body mass index (BMI) 18 to 30 kg/m2 inclusive
  • All subjects must agree to use a barrier method (e.g. condom) throughout the study and for up to 5 months after the last dose of study drug
  • Significant past or present disorders of the central nervous system, psychiatric disorders or behavioral disturbances.

Exclusion criteria

  • Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse
  • Positive for hepatitis B, hepatitis C, or HIV 1 or HIV 2
  • Participation in an investigational drug or device study within 3 months prior to first administration of the study drug
  • Any confirmed allergic reaction against any drug or multiple allergies
  • Dietary restrictions that would prohibit the consumption of standardized meals
  • Positive cotinine test and/or any use of nicotine containing products
  • Clinically relevant history of constipation or bowel disorder
  • Known intolerability to activated charcoal

Treatment and study plan

RO4995819

Drug

single oral dose

Activated Charcoal

Drug

orally 3 times daily, Days 1-7

Primary outcomes

  1. C max: maximum observed plasma concentration

    Time frame: 18 weeks

  2. T max: time of maximum observed plasma concentration

    Time frame: 18 weeks

  3. T1/2: apparent terminal half-life

    Time frame: 18 weeks

  4. AUC: area under the plasma concentration-time curve

    Time frame: 18 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Single-Center, Open-Label, Two-Period Crossover Study to Investigate the Effect of Multiple Doses of Activated Charcoal on the Pharmacokinetics of a Single Oral Dose of RO4995819 in Healthy Subjects.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 4, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.