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

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO4995819; Drug: activated charcoal

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35042

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 2	Drug: RO4995819; single oral dose
EXPERIMENTAL: 1	Drug: RO4995819; single oral dose; Drug: activated charcoal; orally 3 times daily, Days 1-7

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: August 3, 2011
• First Submitted That Met QC Criteria: August 3, 2011
• First Posted (ESTIMATE): August 4, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Antidotes; Charcoal
• Other Study ID Numbers: BP25485; 2011-000916-24 (EUDRACT_NUMBER)