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

Healthy Volunteer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409369
• Other study ID #: BP25485
• Secondary ID: 2011-000916-24
• Status: Completed
• Phase: Phase 1
• First received: August 3, 2011
• Last updated: November 1, 2016
• Start date: August 2011
• Est. completion date: February 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de securite sanitaire des produits de sante
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4995819
single oral dose
• activated charcoal
orally 3 times daily, Days 1-7

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C max: maximum observed plasma concentration		18 weeks	No
Primary	T max: time of maximum observed plasma concentration		18 weeks	No
Primary	T1/2: apparent terminal half-life		18 weeks	No
Primary	AUC: area under the plasma concentration-time curve		18 weeks	No