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

Solid Tumours Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931761
• Other study ID #: D1532C00077
• Status: Completed
• Phase: Phase 1
• First received: August 27, 2013
• Last updated: June 29, 2015
• Start date: October 2013
• Est. completion date: November 2013

Study information

• Verified date: June 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Solid Tumours

Intervention

Drug:
• [C14] selumetinib (oral)
Single oral administration [C14] 75mg

Locations

Country	Name	City	State
United Kingdom	Research Site	Ruddington

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Metabolite profiling and identification in plasma and excreta		Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.	No
Secondary	Pharmacokinetic parameters of selumetinib	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.	No
Secondary	Plasma concentrations of selumetinib		Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days	No
Secondary	Safety	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.	Yes

External Links

•   CSR_Synopsis_D1532C00077.pdf