NCT02046850

To Assess the Effect of Rifampicin on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Study to assess the effect of Rifampicin on the pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers

Detailed description

A 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

Conditions

• Solid Tumours

Interventions

Type	Name	Description
DRUG	selumetinib	Volunteers will receive a single oral dose of 75 mg selumetinib on day 1 (Treatment A).
DRUG	rifampicin	Volunteers will receive single, daily, oral doses of 600 mg rifampicin on Days 4 to 11 (Treatment B).
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).

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2014-01-28
• Last updated: 2014-04-29

Locations

1 site across 1 country: United States