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CompletedNCT01931761Updated Jun 30, 2015

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

A Phase 1 interventional study of [C14] selumetinib (oral) in Solid Tumours, sponsored by AstraZeneca. Completed at 1 site in United Kingdom. Open to male participants aged 50 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-30.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
50 Years to 65 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Solid Tumours

Keywords

  • Pharmacokinetics, mass balance, AZD6244
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    [C14] selumetinib 75mg single dose

    \[C14\] selumetinib 75mg single dose

    Drug: [C14] selumetinib (oral)

Interventions

  • Drug[C14] selumetinib (oral)

    Single oral administration \[C14\] 75mg

    Also known as: Selumetinib

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Pharmacokinetic parameters of selumetinib

    Cmax, tmax, t½, AUC, CL/F, Vz/F, MRT, fe, Ae, CLR

    Time frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.

  3. Plasma concentrations of selumetinib

    Time frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days

  4. Safety

    Adverse events, vital signs, electrocardiogram, haematology, clinical chemistry, urinalysis, physical examination, left ventricular ejection fraction, and opthalmology assessments.

    Time frame: Assessments prior to treatment and after treatment including follow up.

07

Study locations

1 site
  • Research Site
    Ruddington, United Kingdom
08

References and documents

Publications

  • 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. PubMed 27751676 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01931761
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 29, 2013
Start date
Oct 2013
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Jun 30, 2015

Study contacts

Stuart Mair, MD
principal investigator · University of Aberdeen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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