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

NCT01931761 | Completed Phase 1

• 1 other identifier: D1532C00077
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumours

Keywords

Pharmacokinetics, mass balance, AZD6244

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  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

  Assessments prior to treatment and after treatment including follow up.

Study Arms (1)

[C14] selumetinib 75mg single dose

EXPERIMENTAL

\[C14\] selumetinib 75mg single dose

Drug: [C14] selumetinib (oral)

Interventions

[C14] selumetinib (oral) DRUG

Single oral administration \[C14\] 75mg

Also known as: Selumetinib

[C14] selumetinib 75mg single dose

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Ruddington, United Kingdom

Location

Related Publications (1)

• Dymond AW, Howes C, Pattison C, So K, Mariani G, Savage M, Mair S, Ford G, Martin P. Metabolism, Excretion, and Pharmacokinetics of Selumetinib, an MEK1/2 inhibitor, in Healthy Adult Male Subjects. Clin Ther. 2016 Nov;38(11):2447-2458. doi: 10.1016/j.clinthera.2016.09.002. Epub 2016 Oct 15.

  PMID: 27751676 DERIVED

Related Links

• CSR\_Synopsis\_D1532C00077.pdf

MeSH Terms

Interventions

Carbon-14; AZD 6244

Study Officials

• Stuart Mair, MD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: August 29, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 30, 2015

Record last verified: 2015-06

Locations

GB (1)