To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Renal Impaired Subjects and Healthy Subjects

Part of paid clinical trials in Orlando, Florida.

Sponsor
AstraZeneca
Study ID
NCT02063204
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumours

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • selumetinib — DRUG
    selumetinib 50 mg (2x25mg) administered by mouth as capsules

Study Details

A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in subjects with renal impairment and healthy subjects

Key Dates

Start date
Mar 31, 2014
Status verified
Jun 2015
Primary completion
Jul 31, 2014
Completion
Jul 31, 2014

Study Design

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

Arms

  • Experimental: HV selumetinib Stage 1
    Healthy volunteer (HV)group to receive selumetinib 50mg (2x25mg) orally
  • Experimental: ESRD selumetinib Stage 1
    End stage renal disease (ESRD)patients to recieve selumetinib 50mg (2x25mg) orally
  • Experimental: Selumetinib stage 2
    If deemed necessary patients with mild and/or moderate and/or severe renal impairment will recieve selumetinib 50mg(2x25mg) orally

Primary Outcome Measure

Description of the pharmacokinetic(PK) profile in terms of maximum observed plasma concentration (Cmax) [ Time Frame: Samples taken at predose, 30min, 1h, 1h30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h,6h,7h,8h,12h,18h,24h,36h,48h and 76h ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteOrlandoFlorida--

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Research Site· Orlando, FL

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