Study identifier:D1532C00081
ClinicalTrials.gov identifier:NCT02063204
EudraCT identifier:N/A
CTIS identifier:N/A
An Open label Comparative Study of the Pharmacokinetics, Safety and Tolerability of Selumetinib (AZD6244, ARRY 142886) (Hyd Sulfate) following a Single Oral Dose in Subjects with Renal Impairment and Healthy Subjects
Solid tumours
Phase 1
Yes
selumetinib
All
24
Interventional
18 Years - 150 Years
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Feb 2017 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: HV selumetinib Stage 1 Healthy volunteer (HV)group to receive selumetinib 50mg (2x25mg) orally | Drug: selumetinib selumetinib 50 mg (2x25mg) administered by mouth as capsules |
Experimental: ESRD selumetinib Stage 1 End stage renal disease (ESRD)patients to recieve selumetinib 50mg (2x25mg) orally | Drug: selumetinib selumetinib 50 mg (2x25mg) administered by mouth as capsules |
Experimental: Selumetinib stage 2 If deemed necessary patients with mild and/or moderate and/or severe renal impairment will recieve selumetinib 50mg(2x25mg) orally | Drug: selumetinib selumetinib 50 mg (2x25mg) administered by mouth as capsules |