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A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of Brodalumab vs. two doses of Brodalumab
A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single 1.5mL dose of Brodalumab (140mg/mL) vs. two doses (1.0mL + 0.5mL) of Brodalumab (140mg/mL)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brodalumab (single 1.5mL pre-filled syringe) | Experimental | A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection |
|
| Brodalumab (2 pre-filled syringes [1.0mL + 0.5mL]) | Experimental | A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brodalumab | Drug | Brodalumab is a large molecule for the treatment of inflammatory diseases |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B. | Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection | 60 days |
| Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab | Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Presence of binding or neutralizing anti-brodalumab antibodies | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | 91206 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | (Treatment A Day 1-28 + Treatment B Day 29-56) | 210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28)" first, then followed by "Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, treatment A Days 29-56) Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases](streamdown:incomplete-link) |
| FG001 | (Treatment B Days 1-28 + Treatment A Days 29-56) | 210 mg SC Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, Treatment B Days 1-28])" first, then "Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56) Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | (Treatment A Day 1-28 + Treatment B Day 29-56) | 210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28)" first, then followed by "Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, treatment A Days 29-56) Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases](streamdown:incomplete-link) |
| BG001 |
| 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 | Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B. | Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection | Number of participants analyzed reflects the combination of participants analyzed at period one and then again at period two | Posted | Mean | Standard Deviation | milligrams per milliliter | 60 days |
|
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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 Day 1-28 + Treatment B Day 29-56) | 210 mg SC Brodalumab (Single 1.5mL, Pre-filled Syringe, treatment A Days 1-28)" first, then followed by "Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, treatment A Days 29-56) Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases](streamdown:incomplete-link) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Valeant Pharmaceuticals | 908 | lindsey.mathew@valeant.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C571216 | brodalumab |
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| Aventura |
| Florida |
| 33180 |
| United States |
| Research Site | Saint Paul | Minnesota | 55114 | United States |
| Research Site | Lincoln | Nebraska | 68502 | United States |
| Research Site | Austin | Texas | 78744 | United States |
| Research Site | San Antonio | Texas | 78209 | United States |
| (Treatment B Days 1-28 + Treatment 8 Days 29-56) |
210 mg SC Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, Treatment B Days 1-28])" first, then "Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56) Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Treatment B,Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL]) |
A single 210 mg subcutaneous (SC) dose of Brodalumab administered using 2 (1.0mL + 0.5mL) pre-filled syringe injections Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases |
|
|
| Primary | Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab | Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection | Participants analyzed is a combination of period 1 and period 2 participants results, thus the higher number of overall participants analyzed | Posted | Mean | Standard Deviation | (day*mg/mL) | 60 days |
|
|
|
| Secondary | Immunogenicity | Presence of binding or neutralizing anti-brodalumab antibodies | Posted | Number | participants | 60 days |
|
|
|
| 0 |
| 141 |
| 41 |
| 141 |
| EG001 | (Treatment B Days 1-28 + Treatment A Days 29-56) | 210 mg SC Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL, Treatment B Days 1-28])" first, then "Brodalumab (Single 1.5mL Pre-filled Syringe, treatment A Days 29-56) Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases | 0 | 131 | 39 | 131 |
| Oropharyngeal Candidiasis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Injection Site Reaction | General disorders | Non-systematic Assessment |
|
| Hypersensitivity | General disorders | Non-systematic Assessment |
|
| Infections | Infections and infestations | Non-systematic Assessment |
|
| Injection Site haemorrhage | General disorders | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Muscle Strain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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