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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Solid Tumours

Treatments: Drug: rifampicin; Drug: selumetinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02046850

D1532C00085

Details and patient eligibility

About

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

Full 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

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: 1. Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive). 2. Must not have smoked or used nicotine products within the previous 3 months. 3. Have a calculated creatinine clearance (CrCL) greater than 50 mL/min using the Cockcroft-Gault formula.

Exclusion Criteria: 1. Subjects of Japanese or non-Japanese Asian ethnicity. 2. Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (eg, China, Taiwan, Korea, Philippines, Thailand, Vietnam and Malaysia). Asian Indians are acceptable. 3. Current or past history of central serous retinopathy or retinal vein thrombosis,intra-ocular pressure greater than 21 mmHg or uncontrolled glaucoma. 4. Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs or ECG at baseline in the opinion of the investigator. 5. History of presence of any clinically significant disease or disorder in the opinion of the investigator.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

selumetinib 75mg.

Experimental group

Description:

Volunteers will receive selumetinib 75mg administered by mouth, as a capsule

Treatment:

Drug: selumetinib

Drug: selumetinib

rifampicin 600mg.

Other group

Description:

Volunteers will receive rifampicin 600mg administered by mouth, as a capsule

Treatment:

Drug: rifampicin

Drug: rifampicin

selumetinib 75mg and rifampicin 600mg

Experimental group

Description:

Volunteers will receive selumetinib 75mg and rifampicin 600mg, by mouth, as a capsule

Treatment:

Drug: rifampicin

Drug: selumetinib

Drug: selumetinib

Drug: rifampicin