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

NCT01365403 | Completed Phase 1

• 1 other identifier: BP25263
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Area under the concentraion-time curve/maximum concentration (AUC/Cmax) of single dose RO4917838 with multiple dose carbamazepine administration

  approximately 4 weeks

Secondary Outcomes (1)

• Safety: Incidence of adverse events

  up to 13 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: RO4917838; Drug: carbamazepine

Interventions

RO4917838 DRUG

Single oral dose, Day 1 of study period 1 and Day 16 of study period 2

Single Arm

carbamazepine DRUG

multiple oral doses, Days 1-24 of study period 2

Single Arm

Eligibility Criteria

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

You may qualify if:

• Adult healthy male volunteers, 18-65 years of age inclusive
• Body mass index (BMI) 18-30 kg/m2 inclusive

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Rennes, 35042, France

Location

MeSH Terms

Interventions

Carbamazepine

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: June 3, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (1)