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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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01409369
First received: August 3, 2011
Last updated: November 24, 2014
Last verified: November 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 RO 4995819 in healthy volunteers. Each enrolled subject will receive two single ora l 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 multipl e 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 24, 2014
Health Authority: France: Afssaps - Agence française de securite sanitaire des produits de sante

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

ClinicalTrials.gov processed this record on November 25, 2014