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Completed

NCT Number: NCT01931761

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

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

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Key information

Conditions

Solid Tumours

Age range

50 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Ruddington, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[C14] selumetinib (oral)

Drug

Single oral administration [C14] 75mg

Other names: Selumetinib

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

    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

  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

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 29, 2013
Registry last updated
Jun 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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