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A Study to assess, against a reference selumetinib capsule, if the drug levels of a variant of selumetinib capsule are comparable, and to assess how drug levels differed in another variant of Selumetinib in Healthy Male Volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | AZD6244 blue reference capsules (3 x 25 mg) administered orally |
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| Treatment B | Experimental | AZD6244 blue capsules (3 x 25 mg) Variant 1 (free base variant) administered orally |
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| Treatment C | Experimental | AZD6244 blue capsules (3 x 25 mg) Variant 2 (vitamin E polyethylene glycol succinate [TPGS] variant) administered orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selumetinib 75mg single dose | Drug | 3 blue capsules of 25 mg given as a single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib Cmax] | The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the maximum observed plasma concentration (Cmax) of selumetinib in healthy volunteers. | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4). |
| Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC] | The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) of selumetinib in healthy volunteers. | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4). |
| Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC(0-t)] | The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of selumetinib in healthy volunteers. | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4). |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib Cmax] | The relative bioavailability of the TPGS capsule variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the Cmax of selumetinib in healthy volunteers. | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4). |
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Inclusion Criteria:1.Provision of written informed consent 2.Healthy male volunteers aged 18 to 45 years 3.Calculated creatinine clearance (CrCL) >50 mL/minute using the Cockcroft-Gault formula 4.Healthy volunteers with sexual partners who could become pregnant should agree to use 2 highly effective methods of contraception. Healthy volunteers with sexual partners who are pregnant should agree to use an effective method of contraception (barrier method) from the first administration until 12 weeks after the last administration of the investigational product. Healthy volunteers should avoid sperm donation during the study and for 12 weeks after the last administration of the investigational product 5.Use no nicotine containing products for at least 3 months prior to screening 6.For inclusion in the genetic component of the study, healthy volunteers provide written informed consent for genetic research.
Exclusion Criteria:
1.Healthy male volunteers of Japanese or non Japanese Asian, or Indian ethnicity 2.Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian or Indian 3.Involvement in the planning and/or conduct of the study. 4.Previous randomisation to treatment in the present study 5.Participation in another clinical study within 3 month before Visit 1, or participation in a method development study 1 month before Visit 1. 6.Current or past history of central serous retinopathy or retinal vein thrombosis, intraocular pressure greater than 21 mmHg or uncontrolled glaucoma 7.Any clinically significant disease or disorder that may put the healthy volunteer at risk because of participation in the study, influence the result of the study or influence the healthy volunteer's ability to participate in the study 8.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 healthy volunteer at risk because of his participation in the study. 9.Use of prescribed medications and over-the-counter drugs (including herbal remedies) known to have moderate or strong cytochrome P450 (CYP) 3A4 or CYP2C19 inducer or inhibitory effects from 30 days prior to the first administration of investigational product until the follow up visit 10.Use of any other prescribed medications and over-the-counter drugs (including herbal remedies, vitamins and minerals) within 2 weeks or 5 times the half life, whichever is longer, of the respective drug prior to Visit 2, with the exception of occasional use of acetaminophen (paracetamol or TYLENOL®) and over-the-counter adrenergic nasal spray for relief of nasal congestion. No medications known to prolong the QT/corrected QT interval (QTc) interval are allowed 11.Excessive intake of caffeine containing drinks or food. 12.Any intake of grapefruit and Seville oranges or other products containing grapefruit or Seville oranges within 7 days of the first admission 13.A definite or suspected personal history of intolerance or hypersensitivity to drugs and/or their excipients 14.Plasma donation or any blood donation/blood loss greater than 500 mL during the 3 months prior to screening 15.History of, or current alcohol or drug abuse. 16.A suspected/manifested infection according to the International Air Transport Association (IATA) Categories A and B infectious substances 17.Healthy male volunteers who do not agree to use at least 2 effective methods of contraception 18.Positive results at screening for human immunodeficiency virus (HIV) and/or hepatitis B and/or hepatitis C 19.Planned inpatient surgery, dental procedure or hospitalisation during the study 20.Healthy male volunteers who, in the opinion of the Principal Investigator, should not participate in the study 21.Healthy male volunteers with a LVEF <55% 22.Previous bone marrow transplant 23.Whole blood transfusion within 120 days of the genetic sample collection
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| Name | Affiliation | Role |
|---|---|---|
| Olufeyikemi Oluwayi, MBChB | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
48 subjects received at least 1 of the 3 treatments and 45 completed all 3 treatment periods. There was a washout period of 7 to 10 days between administrations. A follow-up visit occurred 7 days after the last administration of the third treatment period.
48 healthy adult males were enrolled in this single centre, randomised, open label, 3-period, 3-treatment and 6-sequence crossover study from 24 February 2015 to study completion on 30 April 2015. Subjects attended the clinical study unit for at least 1 screening visit and 3 treatment periods.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence ABC | Subjects randomized to treatment sequences ABC: A=Selumetinib Blue Reference Capsules; B=Selumetinib Blue Free Base Variant Capsules; C=Selumetinib Blue TPGS Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| selumetinib 75mg single dose | Drug | 3 capsules of 25 mg given as a single dose |
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| selumetinib 75mg single dose | Drug | 3 capsules of 25 mg given as a single dose |
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| Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC] | The relative bioavailability of the TPGS capsules variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC of selumetinib in healthy volunteers. | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4). |
| Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC(0-t)] | The relative bioavailability of the TPGS capsule variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC[0-t] of selumetinib in healthy volunteers. | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4). |
| The PK of the Metabolite N-desmethyl Selumetinib by Assessment of Cmax | The PK of the metabolite N-desmethyl selumetinib was evaluated by assessing the Cmax of the metabolite in healthy volunteers after oral administration of single doses of the blue reference capsule (Treatment A), the free base variant capsule (Treatment B) and the TPGS variant capsule (Treatment C). | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4). |
| The PK of N-desmethyl Selumetinib by Assessment of the AUC(0-t) | The PK of the metabolite N-desmethyl selumetinib was evaluated by assessing the AUC(0-t) of the metabolite in healthy volunteers after oral administration of single doses of the blue reference capsule (Treatment A), the free base variant capsule (Treatment B) and the TPGS variant capsule (Treatment C). | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4). |
| FG001 | Sequence ACB | Subjects randomized to treatment sequences ACB: A=Selumetinib Blue Reference Capsules; C=Selumetinib Blue TPGS Variant Capsules; B=Selumetinib Blue Free Base Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations. |
| FG002 | Sequence BAC | Subjects randomized to treatment sequences BAC: B=Selumetinib Blue Free Base Variant Capsules; A=Selumetinib Blue Reference Capsules; C=Selumetinib Blue TPGS Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations. |
| FG003 | Sequence BCA | Subjects randomized to treatment sequences BCA: B=Selumetinib Blue Free Base Variant Capsules; C=Selumetinib Blue TPGS Variant Capsules; A=Selumetinib Blue Reference Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations. |
| FG004 | Sequence CAB | Subjects randomized to treatment sequences CAB: C=Selumetinib Blue TPGS Variant Capsules; A=Selumetinib Blue Reference Capsules; B=Selumetinib Blue Free Base Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations. |
| FG005 | Sequence CBA | Subjects randomized to treatment sequences CBA: C=Selumetinib Blue TPGS Variant Capsules; B=Selumetinib Blue Free Base Variant Capsules; A=Selumetinib Blue Reference Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations. |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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All randomized subjects (n = 48) were included in the baseline analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All subjects received at least 1 dose of selumetinib. Subjects were randomised in a crossover fashion to receive 1 of 3 treatments during each treatment period: Period 1=Visit 2; Period 2=Visit 3; Period 3=Visit 4. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib Cmax] | The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the maximum observed plasma concentration (Cmax) of selumetinib in healthy volunteers. | The Pharmacokinetic (PK) analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per millilitre (ng/mL) | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4). |
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| Primary | Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC] | The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) of selumetinib in healthy volunteers. | The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng * hour per mL (ng*h/mL) | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4). |
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| Primary | Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC(0-t)] | The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of selumetinib in healthy volunteers. | The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4). |
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| Secondary | Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib Cmax] | The relative bioavailability of the TPGS capsule variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the Cmax of selumetinib in healthy volunteers. | The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4). |
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| Secondary | Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC] | The relative bioavailability of the TPGS capsules variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC of selumetinib in healthy volunteers. | The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4). |
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| Secondary | Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC(0-t)] | The relative bioavailability of the TPGS capsule variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC[0-t] of selumetinib in healthy volunteers. | The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4). |
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| Secondary | The PK of the Metabolite N-desmethyl Selumetinib by Assessment of Cmax | The PK of the metabolite N-desmethyl selumetinib was evaluated by assessing the Cmax of the metabolite in healthy volunteers after oral administration of single doses of the blue reference capsule (Treatment A), the free base variant capsule (Treatment B) and the TPGS variant capsule (Treatment C). | The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4). |
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| Secondary | The PK of N-desmethyl Selumetinib by Assessment of the AUC(0-t) | The PK of the metabolite N-desmethyl selumetinib was evaluated by assessing the AUC(0-t) of the metabolite in healthy volunteers after oral administration of single doses of the blue reference capsule (Treatment A), the free base variant capsule (Treatment B) and the TPGS variant capsule (Treatment C). | The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4). |
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All adverse events (AEs) were collected from randomisation (Visit 2, Day 1) until the follow-up visit (Visit 5).
Visits 2, 3 and 4 comprised 3 separate treatment periods with a washout period of 7 - 10 days between administrations.
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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 | Treatment A: Selumetinib Blue Reference Capsules | Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration). | 0 | 46 | 12 | 46 | ||
| EG001 | Treatment B: Selumetinib Blue Free Base Variant Capsules | Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration). | 0 | 48 | 12 | 48 | ||
| EG002 | Treatment C: Selumetinib Blue TPGS Variant Capsules | Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration). | 0 | 45 | 9 | 45 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharospasm | Eye disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Eye Pruritus | Eye disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Ocular Hyperaemia | Eye disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Catheter Site Bruise | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Catheter Site Pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Catheter Site Related Reaction | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Muscle Strain | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA (17.0) | Non-systematic Assessment |
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| Weight Decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
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| White Blood Cell Count Decreased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
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Neither Party (PI or Sponsor) will use the other Party's name in connection with any publication or promotion without the other Party's prior, written consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Information Centre | AstraZeneca | Information.centre@astrazeneca.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C517975 | AZD 6244 |
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| Withdrawal by Subject |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG002 | Treatment C: Selumetinib Blue TPGS Variant Capsules | Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration). |
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| OG002 | Treatment C: Selumetinib Blue TPGS Variant Capsules | Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration). |
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