Clinical trial · Interventional
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers
A Phase I, Single-centre, Non-randomised, Open-label, Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-Selumetinib in Healthy Male Volunteers
NCT01931761CI-TRIAL-00018407completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose \[14C\] selumetinib in volunteers
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumours | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [C14] selumetinib (oral) | Drug | Selumetinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [C14] selumetinib 75mg single dose
- description
- \[C14\] selumetinib 75mg single dose
- interventionNames
- Drug: [C14] selumetinib (oral)
Primary outcomes (1)
- measure
- Concentration of total radioactivity in blood and plasma and percentage of radioactive dose in urine and faeces and total balance
- timeFrame
- Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days
Secondary outcomes (4)
- measure
- Metabolite profiling and identification in plasma and excreta
- timeFrame
- Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDDymond 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