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To assess the absolute bioavailability of oral selumetinib in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| selumetinib 75mg single dose | Experimental | 3 capsules of 25 mg administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selumetinib 75mg single dose | Drug | 3 capsules of 25 mg given as a single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Bioavailability | To calculate absolute bioavailability we used the formula: Area Under the Curve (oral dose)/Area Under the Curve (intravenous dose)*100 | 0 to 72 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Mair | Quotient Clinical Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nottingham | United Kingdom |
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21 subjects were enrolled, 12 of these subjects went on to receive treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | Selumetinib | Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Selumetinib | Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absolute Bioavailability | To calculate absolute bioavailability we used the formula: Area Under the Curve (oral dose)/Area Under the Curve (intravenous dose)*100 | Posted | Geometric Mean | 90% Confidence Interval | % of bioavailability | 0 to 72 hours post-dose |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Selumetinib | Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head Ache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriella Mariani | AstraZeneca | +44 7818 523 899 | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C517975 | AZD 6244 |
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| [14C] selumetinib IV solution | Other | 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 |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 12 |
| 2 |
| 12 |
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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