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To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose [14C] selumetinib in volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [C14] selumetinib 75mg single dose | Experimental | [C14] selumetinib 75mg single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [C14] selumetinib (oral) | Drug | Single oral administration [C14] 75mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Cmax, tmax, t½, AUC, CL/F, Vz/F, MRT, fe, Ae, CLR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Mair, MD | University of Aberdeen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ruddington | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27751676 | Derived | 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. |
| Label | URL |
|---|---|
| CSR\_Synopsis\_D1532C00077.pdf | View source |
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| ID | Term |
|---|---|
| C000615234 | Carbon-14 |
| C517975 | AZD 6244 |
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| 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 | 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. |