A Bioequivalence Study Comparing a Single 1.5mL Dose of Brodalumab vs. Two Doses (1.0mL + 0.5mL) of Brodalumab
Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02173392
Collaborator
(none)
145
6
2
3
24.2
8.1
Study Details
Study Description
Brief Summary
A healthy subject, 2-way cross-over study to evaluate the bioequivalence of a single dose of Brodalumab vs. two doses of Brodalumab
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
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)
Study Design
Study Type:
Interventional
Actual Enrollment
:
145 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Bioequivalence Study Comparing a Single Subcutaneous Injection With a 1.5 mL Prefilled Syringe Versus 2 Subcutaneous Injections of 1 mL and 0.5 mL Prefilled Syringes of Brodalumab 140 mg/mL to Healthy Subjects
Study Start Date
:
Sep 1, 2014
Actual Primary Completion Date
:
Nov 1, 2014
Actual Study Completion Date
:
Dec 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Brodalumab (single 1.5mL pre-filled syringe) A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection |
Drug: Brodalumab
Brodalumab is a large molecule for the treatment of inflammatory diseases
|
| Experimental: 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 |
Drug: Brodalumab
Brodalumab is a large molecule for the treatment of inflammatory diseases
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B. [60 days]
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
- Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab [60 days]
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
Secondary Outcome Measures
- Immunogenicity [60 days]
Presence of binding or neutralizing anti-brodalumab antibodies
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- healthy males and females with a BMI between 18.0 and 30.0 kg/m2, inclusive. Females must be of non-reproductive potential
Exclusion Criteria:
- no history or evidence of clinically significant disorder that would pose a risk to subject safety or interfere with study evaluation, procedures, or completion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Glendale | California | United States | 91206 |
| 2 | Research Site | Aventura | Florida | United States | 33180 |
| 3 | Research Site | St. Paul | Minnesota | United States | 55114 |
| 4 | Research Site | Lincoln | Nebraska | United States | 68502 |
| 5 | Research Site | Austin | Texas | United States | 78744 |
| 6 | Research Site | San Antonio | Texas | United States | 78209 |
Sponsors and Collaborators
- Bausch Health Americas, Inc.
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT02173392
Other Study ID Numbers:
- 20130307
First Posted:
Jun 25, 2014
Last Update Posted:
Jun 20, 2017
Last Verified:
Apr 1, 2017
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | (Treatment A Day 1-28 + Treatment B Day 29-56) | (Treatment B Days 1-28 + Treatment A Days 29-56) |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Period Title: Overall Study | ||
| STARTED | 73 | 72 |
| COMPLETED | 59 | 68 |
| NOT COMPLETED | 14 | 4 |
Baseline Characteristics
| Arm/Group Title | (Treatment A Day 1-28 + Treatment B Day 29-56) | (Treatment B Days 1-28 + Treatment 8 Days 29-56) | Total |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Total of all reporting groups |
| Overall Participants | 73 | 72 | 145 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
40.6
(10.7)
|
41.1
(10.8)
|
40.8
(10.7)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
30
41.1%
|
24
33.3%
|
54
37.2%
|
| Male |
43
58.9%
|
48
66.7%
|
91
62.8%
|
Outcome Measures
| Title | Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B. |
|---|---|
| Description | 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 |
| Time Frame | 60 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of participants analyzed reflects the combination of participants analyzed at period one and then again at period two |
| Arm/Group Title | Treatment A, Brodalumab (Single 1.5mL Pre-filled Syringe) | Treatment B,Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL]) |
|---|---|---|
| Arm/Group Description | A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases | 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 |
| Measure Participants | 138 | 131 |
| Mean (Standard Deviation) [milligrams per milliliter] |
13.8
(7.85)
|
14.8
(7.70)
|
| Title | Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab |
|---|---|
| Description | 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 |
| Time Frame | 60 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants analyzed is a combination of period 1 and period 2 participants results, thus the higher number of overall participants analyzed |
| Arm/Group Title | Brodalumab (Single 1.5mL Pre-filled Syringe) | Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL]) |
|---|---|---|
| Arm/Group Description | A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases | 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 |
| Measure Participants | 138 | 131 |
| Mean (Standard Deviation) [(day*mg/mL)] |
125
(69)
|
149
(81.5)
|
| Title | Immunogenicity |
|---|---|
| Description | Presence of binding or neutralizing anti-brodalumab antibodies |
| Time Frame | 60 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Brodalumab (Single 1.5mL Pre-filled Syringe) | Brodalumab (2 Pre-filled Syringes [1.0mL + 0.5mL]) |
|---|---|---|
| Arm/Group Description | A single 210 mg subcutaneous (SC) dose of Brodalumab administered using a single 1.5mL pre-filled syringe injection Brodalumab: Brodalumab is a large molecule for the treatment of inflammatory diseases | 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 |
| Measure Participants | 141 | 131 |
| Number [participants] |
0
0%
|
0
0%
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | (Treatment A Day 1-28 + Treatment B Day 29-56) | (Treatment B Days 1-28 + Treatment A Days 29-56) | ||
| Arm/Group Description | 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 | 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 | ||
All Cause Mortality |
||||
| (Treatment A Day 1-28 + Treatment B Day 29-56) | (Treatment B Days 1-28 + Treatment A Days 29-56) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| (Treatment A Day 1-28 + Treatment B Day 29-56) | (Treatment B Days 1-28 + Treatment A Days 29-56) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/141 (0%) | 0/131 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| (Treatment A Day 1-28 + Treatment B Day 29-56) | (Treatment B Days 1-28 + Treatment A Days 29-56) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 41/141 (29.1%) | 39/131 (29.8%) | ||
| Blood and lymphatic system disorders | ||||
| Neutropenia | 4/141 (2.8%) | 3/131 (2.3%) | ||
| Gastrointestinal disorders | ||||
| Oropharyngeal Candidiasis | 1/141 (0.7%) | 1/131 (0.8%) | ||
| Nausea | 3/141 (2.1%) | 2/131 (1.5%) | ||
| Diarrhoea | 2/141 (1.4%) | 1/131 (0.8%) | ||
| General disorders | ||||
| Injection Site Reaction | 3/141 (2.1%) | 3/131 (2.3%) | ||
| Hypersensitivity | 1/141 (0.7%) | 6/131 (4.6%) | ||
| Injection Site haemorrhage | 2/141 (1.4%) | 1/131 (0.8%) | ||
| Infections and infestations | ||||
| Infections | 10/141 (7.1%) | 10/131 (7.6%) | ||
| Upper Respiratory Tract Infection | 5/141 (3.5%) | 2/131 (1.5%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Muscle Strain | 2/141 (1.4%) | 3/131 (2.3%) | ||
| Nervous system disorders | ||||
| Headache | 10/141 (7.1%) | 7/131 (5.3%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Director of Clinical Trials |
|---|---|
| Organization | Valeant Pharmaceuticals |
| Phone | 908 |
| lindsey.mathew@valeant.com |
Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT02173392
Other Study ID Numbers:
- 20130307
First Posted:
Jun 25, 2014
Last Update Posted:
Jun 20, 2017
Last Verified:
Apr 1, 2017