Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 83 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01365403
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE May 20, 2011
First Posted Date  ICMJE June 3, 2011
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE April 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2011)
Area under the concentraion-time curve/maximum concentration (AUC/Cmax) of single dose RO4917838 with multiple dose carbamazepine administration [ Time Frame: approximately 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2011)
Area under the concentration-time curve/maximum concentration (AUC/Cmax) of single dose RO4917838 with multiple dose carbamazepine administration [ Time Frame: approximately 4 weeks ]
Change History Complete list of historical versions of study NCT01365403 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2011)
Safety: Incidence of adverse events [ Time Frame: up to 13 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on The Effect of Multiple Dose Carbamazepine on Single Dose Pharmacokinetics of RO4917838 in Healthy Volunteers
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • Drug: RO4917838
    Single oral dose, Day 1 of study period 1 and Day 16 of study period 2
  • Drug: carbamazepine
    multiple oral doses, Days 1-24 of study period 2
Study Arms  ICMJE Experimental: Single Arm
Interventions:
  • Drug: RO4917838
  • Drug: carbamazepine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2011)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01365403
Other Study ID Numbers  ICMJE BP25263
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP