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

June 29, 2015 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [C14] selumetinib 75mg single dose
Drug: [C14] selumetinib (oral)
Single oral administration [C14] 75mg
Other Names:
  • Selumetinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of total radioactivity in blood and plasma and percentage of radioactive dose in urine and faeces and total balance
Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days
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
Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Pharmacokinetic parameters of selumetinib
Time Frame: 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
Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Plasma concentrations of selumetinib
Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days
Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days
Safety
Time Frame: 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.
Assessments prior to treatment and after treatment including follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Stuart Mair, MD, University of Aberdeen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

June 30, 2015

Last Update Submitted That Met QC Criteria

June 29, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D1532C00077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Solid Tumours

Clinical Trials on [C14] selumetinib (oral)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe