Healthy Volunteers Bioavailability StudyPhase 1NCT02238782
A Study to Assess the Absolute Bioavailability of Oral Selumetinib in Healthy Male Volunteers.
A Phase 1 study testing selumetinib 75mg single dose and [14C] selumetinib IV solution in people with Healthy Volunteers Bioavailability Study, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
To assess the absolute bioavailability of oral selumetinib in healthy male volunteers Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers Bioavailability Study
- What is being tested?
- selumetinib 75mg single dose and [14C] selumetinib IV solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Nov 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- Healthy male volunteers aged 18 to 65
- Male volunteers with sexual partners who are pregnant or who could become pregnant should use two highly effective methods of contraception (including one barrier method) for at least 14 days after completing the study and should avoid sperm donation for 14 days after study completion.
- Body mass index between 18 and 30 kg/m2 and weighing between 50 and 100 kg.
- Use no nicotine containing products for at least 3 months prior to screening with a negative cotinine screen at screening and Day 1 (Visit 2)
- Calculated creatinine clearance greater than 50 mL/min using Cockcroft Gault formula.
Who cannot join
- Involvement in the planning and/or conduct of the study
- Previous enrolment for treatment in the present study
- Japanese or non Japanese Asian or Indian ethnicity.
- Any one parent or grandparent is Japanese or non-Japanese Asian or Indian.
- Treatment with another new chemical entity or participation in any other clinical study that included drug treatment within at least 3 months
- Participation in another clinical study involving administration of [14C] radioactivity within 1 year.
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- Current or past history of central serious retinopathy or retinal vein thrombosis, intraocular pressure greater than 21 mmHg or uncontrolled glaucoma.
- Any clinically significant disease or disorder which, may put the volunteer at risk because of participation in the study, influence the study result or influence the volunteer's ability to participate in the study.
- Any clinically relevant abnormal findings in physical examination, haematology, clinical chemistry, urinalysis, vital signs or 12 lead ECG at Visit 1, which may put the volunteer at risk because of his participation in the study.
- Use of drugs with enzyme inducing properties such as St John's Wort within 4 weeks prior to the administration of the investigational product
- Use of any other prescribed medicine and over the counter drugs within 2 week or 5 times the half life, whichever is longer prior to the administration of the investigational product up to and including the follow up visit (Visit 4), with the exception of occasional use of paracetamol or ibuprofen and over the counter adrenergic nasal spray. No medications known to prolong the QT/corrected QT interval are allowed.
- Excessive intake of caffeine containing drinks or food
- Any intake of grapefruit and Seville oranges including products containing grapefruit or Seville oranges within 7 days of the admission on Day -1.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to Selumetinib.
- Plasma donation within 1 month of screening (Visit 1) or any blood donation or blood loss greater than 500 mL during the 3 months prior to screening (Visit 1).
- History of or current alcohol or drug abuse.
- A suspected or manifested infection according to the International Air Transport Association Categories A and B infectious substances.
- Positive results on screening tests for HIV and/or hepatitis B and/or hepatitis C.
- Baseline LVEF <55% measured by echocardiography.
- Planned inpatient surgery, dental procedure or hospitalisation during the study.
- Healthy male volunteers who in the opinion of the Principal Investigator, should not participate in the study.
- Judgment by Principal Investigator that the volunteer should not participate in the study if they have ongoing or recent minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Selumetinib With Respect to an Intravenous Microdose of [14C] Selumetinib in Healthy Male Volunteers
To assess the absolute bioavailability of oral selumetinib in healthy male volunteers
- Conditions
- Healthy Volunteers Bioavailability Study
- Being tested
- selumetinib 75mg single dose, [14C] selumetinib IV solution
- Keywords
- bioavailability, pharmacokinetics, I phase, AZD6244, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selumetinib 75mg single doseDrug
Also called Selumetinib
3 capsules of 25 mg given as a single dose
[14C] selumetinib IV solutionOther
single, radiolabeled, IV (infused), microdose (80 μg) of [14C] selumetinib, infused using a syringe pump as a 15-minute infusion, administered 1h 15 min after receiving the oral dose
| Study group | Role | What they receive |
|---|---|---|
| selumetinib 75mg single dose | Experimental | 3 capsules of 25 mg administered orally Receives: Drug: selumetinib 75mg single dose; Other: [14C] selumetinib IV solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Bioavailability
To calculate absolute bioavailability we used the formula: Area Under the Curve (oral dose)/Area Under the Curve (intravenous dose)*100
Measured: 0 to 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Volunteers Bioavailability StudyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Mair, Principal investigator, Quotient Clinical Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02238782
- Sponsor's protocol ID
- D1532C00080
- Status last verified
- Mar 2016
- First submitted
- 8 Aug 2014
- Last updated
- 5 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Absolute Bioavailability of a Single Oral Dose of Selumetinib With Respect to an Intravenous Microdose of [14C] Selumetinib in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02238782
- Acronym / sponsor ID
- D1532C00080
- Conditions
- Healthy Volunteers Bioavailability Study
- Keywords
- bioavailability, pharmacokinetics, I phase, AZD6244, cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Posted 5 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the absolute bioavailability of oral selumetinib in healthy male volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| selumetinib 75mg single dose | Experimental | Drug: selumetinib 75mg single dose, Other: [14C] selumetinib IV solution3 capsules of 25 mg administered orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of written informed consent
- Healthy male volunteers aged 18 to 65
- Male volunteers with sexual partners who are pregnant or who could become pregnant should use two highly effective methods of contraception (including one barrier method) for at least 14 days after completing the study and should avoid sperm donation for 14 days after study completion.
- Body mass index between 18 and 30 kg/m2 and weighing between 50 and 100 kg.
- Use no nicotine containing products for at least 3 months prior to screening with a negative cotinine screen at screening and Day 1 (Visit 2)
Key exclusion criteria (22 listed)
- Involvement in the planning and/or conduct of the study
- Previous enrolment for treatment in the present study
- Japanese or non Japanese Asian or Indian ethnicity.
- Any one parent or grandparent is Japanese or non-Japanese Asian or Indian.
- Treatment with another new chemical entity or participation in any other clinical study that included drug treatment within at least 3 months
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 |
|---|---|---|
| selumetinib 75mg single doseAlso: Selumetinib3 capsules of 25 mg given as a single dose | Drug | selumetinib 75mg single dose |
| [14C] selumetinib IV solutionsingle, radiolabeled, IV (infused), microdose (80 μg) of [14C] selumetinib, infused using a syringe pump as a 15-minute infusion, administered 1h 15 min after receiving the oral dose | Other | selumetinib 75mg single dose |
Primary outcome
Absolute Bioavailability
Time frame: 0 to 72 hours post-dose
To calculate absolute bioavailability we used the formula: Area Under the Curve (oral dose)/Area Under the Curve (intravenous dose)*100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 principal investigator
Quotient Clinical Ltd
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 selumetinib 75mg single dose and [14C] selumetinib IV solution in people with Healthy Volunteers Bioavailability Study, 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 6 inclusion and 22 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 5 Apr 2016. 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?
Yes. Results are posted in the registry (first posted 5 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Bioavailability (time frame: 0 to 72 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2016.