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

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. Identifier: NCT01409369
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO4995819 Drug: activated charcoal Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
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.
Study Start Date : August 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01409369

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

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

Additional relevant MeSH terms:
Protective Agents
Physiological Effects of Drugs