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

NCT01981005 | Completed Phase 1

• 1 other identifier: NP28989
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Elimination: Amount of drug excreted in urine/feces over the study period

  Days 11 to 15

• Pharmacokinetics: Bioavailability (Area under the plasma concentration-time curve [AUC]) after administration of RO5424802

  Days 1 to 25

Secondary Outcomes (2)

• Safety: Incidence of adverse events

  Days 1 to 25

• Pharmacokinetics: Metabolite identification in plasma, urine, and feces.

  Days 11 to 25

Study Arms (1)

RO5424802

EXPERIMENTAL

Drug: RO5424802

Interventions

RO5424802 DRUG

Single oral doses followed by IV or oral administration of a 14C-labeled tracer

RO5424802

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Zuidlaren, 9471 GP, Netherlands

Location

MeSH Terms

Interventions

alectinib

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 11, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

NL (1)