Solid TumoursPhase 1NCT01931761
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers
A Phase 1 study testing [C14] selumetinib (oral) in people with Solid Tumours, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose [14C] selumetinib in volunteers Read more about this study
- Who is it for?
- Ages 50 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Solid Tumours
- What is being tested?
- [C14] selumetinib (oral)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose [14C] selumetinib in volunteers
- Conditions
- Solid Tumours
- Being tested
- [C14] selumetinib (oral)
- Keywords
- Pharmacokinetics, mass balance, AZD6244
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[C14] selumetinib (oral)Drug
Also called Selumetinib
Single oral administration [C14] 75mg
| Study group | Role | What they receive |
|---|---|---|
| [C14] selumetinib 75mg single dose | Experimental | [C14] selumetinib 75mg single dose Receives: Drug: [C14] selumetinib (oral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of total radioactivity in blood and plasma and percentage of radioactive dose in urine and faeces and total balance
Measured: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days
Secondary outcomes (4)
Metabolite profiling and identification in plasma and excreta
Measured: 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
Measured: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Plasma concentrations of selumetinib
Measured: 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.
Measured: Assessments prior to treatment and after treatment including follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumoursStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Mair, MD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931761
- Sponsor's protocol ID
- D1532C00077
- Status last verified
- Jun 2015
- First submitted
- 27 Aug 2013
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01931761
- Acronym / sponsor ID
- D1532C00077
- Conditions
- Solid Tumours
- Keywords
- Pharmacokinetics, mass balance, AZD6244
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose [14C] selumetinib in volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [C14] selumetinib 75mg single dose | Experimental | Drug: [C14] selumetinib (oral)[C14] selumetinib 75mg single dose |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [C14] selumetinib (oral)Also: SelumetinibSingle oral administration [C14] 75mg | Drug | [C14] selumetinib 75mg single dose |
Primary outcome
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
4 secondary outcomes
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.
Pharmacokinetic parameters of selumetinib
Time frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Plasma concentrations of selumetinib
Time frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days
Safety
Time frame: Assessments prior to treatment and after treatment including follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
- Derived from this study: PubMed 27751676Dymond 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.
- CSR\_Synopsis\_D1532C00077.pdfLink provided by the sponsor.
Related trials for Solid Tumours
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Mair, MD principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [C14] selumetinib (oral) in people with Solid Tumours, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01931761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.