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

NCT01409369 | Completed Phase 1

• 2 other identifiers: BP254852011-000916-24
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: RO4995819; Drug: activated charcoal

2

ACTIVE COMPARATOR

Drug: RO4995819

Interventions

RO4995819 DRUG

single oral dose

1; 2

activated charcoal DRUG

orally 3 times daily, Days 1-7

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Rennes, 35042, France

Location

MeSH Terms

Interventions

Charcoal

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 4, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (1)