A Study on The Effect of Multiple Dose Carbamazepine on Single Dose Pharmacokinetics of RO4917838 in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE, TWO-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE CARBAMAZEPINE ON SINGLE DOSE PHARMACOKINETICS OF RO4917838 IN HEALTHY MALE VOLUNTEERS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365403
• Other study ID #: BP25263
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2011
• Last updated: November 1, 2016
• Start date: April 2011
• Est. completion date: July 2011

Study information

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

Clinical Trial Summary

This open-label, fixed sequence, two-period study will assess the effect of multiple dose carbamazepine on the single dose pharmacokinetics of RO4917838. Subjects will receive a single oral dose of RO4917838 on Day 1 of the 12-day study period 1 and, after a washout of 3-6 weeks, in study period 2 carbamazepine orally daily on Days 1-24 with a single oral dose of RO4917838 on Day 16.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult healthy male volunteers, 18-65 years of age inclusive

• Body mass index (BMI) 18-30 kg/m2 inclusive

Exclusion Criteria:

• History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator

• History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic or psychiatric disease, or cancer

• Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator

• Native Asians or subjects with Asian racial origin

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4917838
Single oral dose, Day 1 of study period 1 and Day 16 of study period 2
• carbamazepine
multiple oral doses, Days 1-24 of study period 2

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	Area under the concentraion-time curve/maximum concentration (AUC/Cmax) of single dose RO4917838 with multiple dose carbamazepine administration		approximately 4 weeks	No
Secondary	Safety: Incidence of adverse events		up to 13 weeks	No