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

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

Official Title
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A Phase I, Single-centre, Non-randomised, Open-label, Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-Selumetinib in Healthy Male Volunteers

Conditions
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Solid Tumours

Intervention / Treatment
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* Drug: [C14] selumetinib (oral)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [C14] selumetinib 75mg single dose<br>[C14] selumetinib 75mg single dose | Drug: [C14] selumetinib (oral)<br>* Single oral administration [C14] 75mg<br>* Other names: Selumetinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of total radioactivity in blood and plasma and percentage of radioactive dose in urine and faeces and total balance |  | Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolite profiling and identification in plasma and excreta |  | Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. | 
| Pharmacokinetic parameters of selumetinib | Cmax, tmax, t½, AUC, CL/F, Vz/F, MRT, fe, Ae, CLR | Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. | 
| Plasma concentrations of selumetinib |  | Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days | 
| Safety | Adverse events, vital signs, electrocardiogram, haematology, clinical chemistry, urinalysis, physical examination, left ventricular ejection fraction, and opthalmology assessments. | Assessments prior to treatment and after treatment including follow up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, mass balance, AZD6244