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A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01629368
First received: June 25, 2012
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This single-center, open-label, cross-over study will evaluate the effect of carbamazepine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of carbamazepine in a cross-over design. The anticipated time on study treatment is 40 days.


Condition Intervention Phase
Healthy Volunteer
 Drug: RO4917523
Drug: Carbamazepine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Single-Center, Open-Label, One-Sequence, Crossover Study to Investigate the Effects of Multiple Doses of Carbamazepine on the Pharmacokinetics of a Single Dose RO4917523 in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: Area under the concentration time curve [ Time Frame: Period 1: Pre-dose and up to Day 14, Period 2: Pre-dose and up to Day 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: incidence of adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dosing Period 1 Drug: RO4917523
Single dose of RO4917523
Experimental: Dosing Period 2 Drug: RO4917523
Single dose of RO4917523
Drug: Carbamazepine
Multiple doses of carbamazepine

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers, 18-65 years of age inclusive
  • Non-smokers
  • Body mass index (BMI) between 18 and 30 mg/m2 inclusive
  • Women who are not menopausal or surgically sterile agree to use two adequate methods of contraception

Exclusion Criteria:

  • Evidence of any active or chronic disease
  • History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer
  • History or presence of clinically significant psychiatric condition
  • Any condition or disease that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629368

Locations
France
Rennes, France, 35042
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01629368     History of Changes
Other Study ID Numbers: BP28256, 2012-000771-16
Study First Received: June 25, 2012
Last Updated: June 3, 2013
Health Authority: France: ANSM - French Health Products Safety Agency

Additional relevant MeSH terms:
Carbamazepine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 18, 2013