Study identifier:D1532C00085
ClinicalTrials.gov identifier:NCT02046850
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I Open-label, Single-center Study to Assess the Effect of the CYP3A4 inducer Rifampicin on the Pharmacokinetics of a 75 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Volunteers aged 18 to 45 years
Solid tumours
Phase 1
Yes
selumetinib, rifampicin
Male
47
Interventional
18 Years - 45 Years
Allocation: N/A
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Feb 2017 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: selumetinib 75mg. Volunteers will receive selumetinib 75mg administered by mouth, as a capsule | Drug: selumetinib Volunteers will receive a single oral dose of 75 mg selumetinib on day 1 (Treatment A). Other Name: AZD6244 |
Other: rifampicin 600mg. Volunteers will receive rifampicin 600mg administered by mouth, as a capsule | Drug: rifampicin Volunteers will receive single, daily, oral doses of 600 mg rifampicin on Days 4 to 11 (Treatment B). Other Name: AZD6244 |
Experimental: selumetinib 75mg and rifampicin 600mg Volunteers will receive selumetinib 75mg and rifampicin 600mg, by mouth, as a capsule | Drug: selumetinib On day 12 volunteers will receive a single oral dose of 75 mg selumetinib (Treatment C). Drug: rifampicin On day 12 volunteers will receive a single oral dose of 600 mg rifampicin. Once daily rifampicin administrations will continue through to Day 14 (Treatment C). |