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

Phase 1

Completed

• Conditions: Solid Tumours
• Interventions: Drug: [C14] selumetinib (oral)

• Registration Number: NCT01931761
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-29
• Study Start: 2013-10
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-29
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[C14] selumetinib 75mg single dose	[C14] selumetinib (oral)	\[C14\] selumetinib 75mg single dose

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Ruddington, United Kingdom