To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: Selumetinib 50mg; Drug: Selumetinib 25mg

• Registration Number: NCT02063230
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

An open label study to assess the pharmcokinetics, safety and tolerability of a single dose of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.

Study Timeline

• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-14
• Study Start: 2014-03
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2015-10-05
• Results First Submitted QC: 2015-10-05
• Results First Posted: 2015-11-01
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-21
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Selumetinib mild impairment	Selumetinib 50mg	Mild (Child Pugh A) hepatic impaired patients
Selumetinib moderate impairment	Selumetinib 50mg	Moderate (Child Pugh B) hepatic impaired patients
Selumetinib severe impairment	Selumetinib 25mg	Severe (Child Pugh C) hepatic impairment patients
Selumetinib HV	Selumetinib 50mg	Healthy volunteers (HV)

Primary Outcome Measures

Name	Time	Method
AUC (0 to Infinity) of Total Selumetinib	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Cmax of Total Selumetinib	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Dose Normalized AUC, Unbound Selumetinib	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Dose Normalized Cmax, Unbound Selumetinib	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Dose Normalized AUC, Total Selumetinib	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose
Dose Normalized Cmax, Total Selumetinib	0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose

Trial Locations

Locations (1)

Research Site; 🇺🇸 Orlando, Florida, United States