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

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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

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

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO5424802 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Alectinib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: RO5424802 Drug: RO5424802
Single oral doses followed by IV or oral administration of a 14C-labeled tracer



Primary Outcome Measures :
  1. Elimination: Amount of drug excreted in urine/feces over the study period [ Time Frame: Days 11 to 15 ]
  2. Pharmacokinetics: Bioavailability (Area under the plasma concentration-time curve [AUC]) after administration of RO5424802 [ Time Frame: Days 1 to 25 ]

Secondary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: Days 1 to 25 ]
  2. Pharmacokinetics: Metabolite identification in plasma, urine, and feces. [ Time Frame: Days 11 to 25 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981005


Locations
Netherlands
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01981005     History of Changes
Other Study ID Numbers: NP28989
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016