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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01409369
First received: August 3, 2011
Last updated: April 7, 2014
Last verified: April 2014
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • T max: time of maximum observed plasma concentration [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • T1/2: apparent terminal half-life [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • AUC: area under the plasma concentration-time curve [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409369

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01409369     History of Changes
Other Study ID Numbers: BP25485, 2011-000916-24
Study First Received: August 3, 2011
Last Updated: April 7, 2014
Health Authority: France: Afssaps - Agence française de securite sanitaire des produits de sante

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

ClinicalTrials.gov processed this record on April 16, 2014