Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Solid Tumours

Treatments: Drug: [C14] selumetinib (oral)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01931761

D1532C00077

Details and patient eligibility

About

To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose [14C] selumetinib in volunteers

Enrollment: 6 patients

Sex: Male

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive.
• Regular bowel movements (ie, on average production of at least 1 stool per day).

Exclusion criteria

• Current or past history of central serous retinopathy or retinal vein thrombosis, intraocular pressure greater than 21 mmHg or uncontrolled glaucoma.
• Exposure to radiation levels above background exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
• History or presence of any clinically significant disease or disorder in the opinion of the investigator
• Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results, vital signs or ECG at baseline 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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6 participants in 1 patient group

[C14] selumetinib 75mg single dose

Experimental group

Description:

\[C14\] selumetinib 75mg single dose

Treatment:

Drug: [C14] selumetinib (oral)