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Trial record 23 of 37 for:    ALECTINIB

A Study of the Elimination, Pharmacokinetics, and Metabolism of RO5424802

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: NCT01981005
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE November 5, 2013
First Posted Date  ICMJE November 11, 2013
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2014)
  • Elimination: Amount of drug excreted in urine/feces over the study period [ Time Frame: Days 11 to 15 ]
  • Pharmacokinetics: Bioavailability (Area under the plasma concentration-time curve [AUC]) after administration of RO5424802 [ Time Frame: Days 1 to 25 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 8, 2013)
  • Pharmacokinetics: Bioavailability (Area under the plasma concentration-time curve [AUC]) after administration of RO5424802 [ Time Frame: Days 1 to 25 ]
  • Elimination: Amount of drug excreted in urine/feces over the study period [ Time Frame: Days 11 to 15 ]
Change History Complete list of historical versions of study NCT01981005 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
  • Safety: Incidence of adverse events [ Time Frame: Days 1 to 25 ]
  • Pharmacokinetics: Metabolite identification in plasma, urine, and feces. [ Time Frame: Days 11 to 25 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2013)
  • Safety: Incidence of adverse events [ Time Frame: Days 1 to 25 ]
  • Pharmacokinetics: Metabolite indentification in plasma, urine, and feces. [ Time Frame: Days 11 to 25 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Elimination, Pharmacokinetics, and Metabolism of RO5424802
Official Title  ICMJE A PHASE 1, SINGLE-CENTER, OPEN-LABEL STUDY INVESTIGATING THE EXCRETION BALANCE, PHARMACOKINETICS AND METABOLISM OF A SINGLE ORAL DOSE AND PHARMACOKINETICS OF AN INTRAVENOUS TRACER OF [14-C]-RO5424802 IN HEALTHY MALE SUBJECTS
Brief Summary This non-randomized, single group, open-label study will investigate the mass balance, routes of elimination, pharmacokinetics, and metabolism of a single oral dose of RO5424802 and the pharmacokinetics of a 14C-labeled tracer in healthy volunteers
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)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE Drug: RO5424802
Single oral doses followed by IV or oral administration of a 14C-labeled tracer
Study Arms  ICMJE Experimental: RO5424802
Intervention: Drug: RO5424802
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: November 8, 2013)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male adults, 18 to 45 years of age, inclusive
  • Body mass index (BMI) from 18 to 32 kg/m2, inclusive
  • Willingness to use effective contraception as outlined in the protocol
  • Willingness to abstain from alcohol and xanthine-containing beverages or food (coffee, tea, cola, chocolate and "energy drinks") from 72 hours prior to the first dose until discharged
  • Willingness to avoid prolonged sun exposure and guard against sunburn during study & follow-up

Exclusion Criteria:

  • Clinically significant medical history or findings in physical examination, vital signs, or laboratory test results prior to study start
  • Positive screening tests for hepatitis B or C, HIV, alcohol, drugs of abuse, or tobacco
  • Regular smoking within 6 months prior to first dosing. Subjects should avoid smoky environments for at least 1 week prior to each cotinine screen
  • Excessive alcohol consumption
  • Use of any metabolic inducers (including herbals such as St. John's Wort) within 4 weeks or 5 half-lives (whichever is longer) before the first dose of study medication, including but not limited to: rifampin, rifabutin, glucocorticoids, carbamazepine, phenytoin and phenobarbital
  • Regular work with ionizing radiation or radioactive material
  • Subjects enrolled in a previous radiolabel study or who have received radiotherapy within 12 months prior to first dosing such that total radioactivity over a 12 month period would exceed an acceptable radiation burden > 0.1 mSv
  • Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work or participation in a medical trial in the previous year
  • Strenuous activity, sunbathing, or contact sports are not allowed from 4 days prior to entry into the clinical site until study follow-up
  • Participation in an investigational drug or device study within 60 days (or 6 months for biologic therapies) prior to first dosing
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01981005
Other Study ID Numbers  ICMJE NP28989
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