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

NCT01960374 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2014-06-02

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers Pharmacokinetic Study

Interventions

DRUG

Selumetinib

1, 2 or 3 x 25 mg selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) capsule administered orally as a single dose on Day 1 of the study (total dose 25 mg, 50 mg and 75 mg respectively) with 240 ml of water at room temperature.

Sponsors & Collaborators

Principal Investigators

  • Ian C Smith, MD · AstraZeneca UK, MSD

  • Ulrike Lorch, MD · Richmond Pharmacology Ltd, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01960374 on ClinicalTrials.gov