Pharmacokinetics of Dabrafenib in Subjects With Renal Impairment

Part of paid clinical trials in DeBary, Florida.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02852239
Phase
PHASE1
Status
Completed

Conditions

  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

Study Details

To characterize the pharmacokinetics and safety of dabrafenib following a single 100 mg oral dose in subjects with severe renal impairment and end stage renal disease not on dialysis.

Key Dates

Start date
Dec 19, 2016
Status verified
Jul 2020
Primary completion
Sep 27, 2019
Completion
Sep 27, 2019

Study Design

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

Arms

  • Experimental: Group 1 - Normal renal function
    Subjects with normal renal function defined as GFR ≥ 90 mL/min at baseline and matching to the renal impaired subject based on gender, race, age, and weight.
  • Experimental: Group 2 - Severe renal function
    Subjects with severe renal impairment defined as GFR of 15-29 mL/min at baseline.
  • Experimental: Group 3 - End stage renal disease (ESRD)
    Subjects with end stage renal disease (ESRD), defined as GFR of \<15 mL/min at baseline.

Primary Outcome Measure

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

Locations (3)

FacilityCityStateZIPSite coordinators
Omega Research Consultants LLCDeBaryFlorida32713-
Hassman Research InstituteBerlinNew Jersey08009-
Wake Research Associates OncologyRaleighNorth Carolina27612-

Find similar trials in DeBary, FL

By research site
Omega Research Consultants LLC· DeBary, FLHassman Research Institute· Berlin, NJWake Research Associates Oncology· Raleigh, NC

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