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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01409369

Enrollment

Registered

2011-08-04

Start date

2011-08-31

Completion date

2012-02-29

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGRO4995819

single oral dose

DRUGactivated charcoal

orally 3 times daily, Days 1-7

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026