drugset / Trial / NCT01960374
Dose-escalation Study to Assess Selumetinib Safety, Tolerability and PK
Non-randomizedParallel-groupOpen-labelHealth-services research
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.
Timeline
- Start
- 2013-10
- Primary completion
- 2014-05
- Completion
- 2014-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Selumetinib | Small molecule | 25 mg | Oral |
| Subject | Selumetinib | Small molecule | 50 mg | Oral |
| Subject | Selumetinib | Small molecule | 75 mg | Oral |
Indications
No indication recorded.