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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01409369
First Posted: August 4, 2011
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition Intervention Phase
Healthy Volunteer Drug: RO4995819 Drug: activated charcoal Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • C max: maximum observed plasma concentration [ Time Frame: 18 weeks ]
  • T max: time of maximum observed plasma concentration [ Time Frame: 18 weeks ]
  • T1/2: apparent terminal half-life [ Time Frame: 18 weeks ]
  • AUC: area under the plasma concentration-time curve [ Time Frame: 18 weeks ]

Enrollment: 26
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO4995819
single oral dose
Drug: activated charcoal
orally 3 times daily, Days 1-7
Active Comparator: 2 Drug: RO4995819
single oral dose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409369


Locations
France
Rennes, France, 35042
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01409369     History of Changes
Other Study ID Numbers: BP25485
2011-000916-24 ( EudraCT Number )
First Submitted: August 3, 2011
First Posted: August 4, 2011
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Charcoal
Antidotes
Protective Agents
Physiological Effects of Drugs