Pharmacokinetics of Dabrafenib in Subjects With Hepatic Impairment

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02873650
Phase
PHASE1
Status
Terminated

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • dabrafenib — DRUG
    Single dose of 100 mg dabrafenib on Day 1

Study Details

To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral dose in subjects with moderate and severe hepatic impairment.

Key Dates

Start date
Dec 20, 2016
Status verified
Apr 2020
Primary completion
Oct 12, 2018
Completion
Apr 8, 2019

Study Design

Enrollment
5 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 1 - Control group
  • Experimental: Group 2-Moderate hepatic impairment
  • Experimental: Group 3-Severe hepatic impairment

Primary Outcome Measure

Maximum plasma concentration (Cmax) [ Time Frame: Predose through 96 hours postdose ]

Locations (4)

FacilityCityStateZIPSite coordinators
American Institute of ResearchLos AngelesCalifornia900017-
Omega Research Consultants LLCDeBaryFlorida32713-
Hassman Research InstituteBerlinNew Jersey08009-
Wake Research Associates OncologyRaleighNorth Carolina27612-

Find similar trials in Los Angeles, CA

By research site
American Institute of Research· Los Angeles, CAOmega Research Consultants LLC· DeBary, FLHassman Research Institute· Berlin, NJWake Research Associates Oncology· Raleigh, NC

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