Spots Global Cancer Trial Database for Dose-escalation Study to Assess Selumetinib Safety, Tolerability and PK

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Trial Identification

Brief Title: Dose-escalation Study to Assess Selumetinib Safety, Tolerability and PK

Official Title: A Phase I, Single-centre, Open-label, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Selumetinib Given Orally in Japanese and Non-Japanese Asian Healthy Male Volunteers

Study ID: NCT01960374

Conditions

Healthy Volunteers Pharmacokinetic Study

Interventions

Selumetinib

Study Description

Brief Summary: The purpose of the study is to assess the safety, tolerability and PK of selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in healthy male Japanese and non-Japanese Asian volunteers following administration of a single dose. Standard safety assessments including ECGs, vital signs, blood/urine safety tests, PK samples and monitoring of adverse events and an optional exploratory pharmacogenetics will be performed.

Detailed Description: A Phase I, Single-centre, Open-label, Dose-escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) Given Orally in Japanese and Non-Japanese Asian Healthy Male Volunteers