- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03236844
Relative Bioavailability of Gantenerumab Produced by G4 Process Versus G3 Process Following Subcutaneous (SC) Injection in Healthy Participants
December 11, 2018 updated by: Hoffmann-La Roche
A Multi-Center, Randomized, Open-Label, Single-Dose, Parallel Group Study to Investigate the Relative Bioavailability of Gantenerumab Produced With the G4 Process in Comparison to Gantenerumab Produced With the G3 Process Following Administration by Subcutaneous Injection in Healthy Volunteers
The purpose of this study is to assess the relative bioavailability of the high concentration liquid formulation (HCLF) of gantenerumab produced with the G4 process in comparison to the same HCLF of gantenerumab produced with the G3 process in healthy participants following single SC dose administration.
Study Overview
Detailed Description
This multi-center, randomized, open-label, single dose, parallel-group study will assess the relative bioavailability and the safety and tolerability of gantenerumab produced with the G4 process in comparison to gantenerumab produced with the G3 process.
All participants will receive single SC dose of gantenerumab (manufactured by either the G3 or G4 process) on Day 1.
The total duration of the study for each participant will be up to 21 weeks: Screening (up to 8 weeks); In-clinic period (Days -1 to 3); Out-patient period (Days 4 up to 68); and Safety Follow-up (up to 90 days after dosing).
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kansas
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Lenexa, Kansas, United States, 66219
- PRA International Clinical Pharmacology Center (EDS US Clinic)
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New Jersey
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Marlton, New Jersey, United States, 08053
- PRA
-
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Utah
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Salt Lake City, Utah, United States, 84106
- PRA Health Sciences
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy participant
- Body mass index (BMI) between 18.0 and 30.0 kilograms per meter-square (kg/m^2), inclusive
- Body weight between 55 to 110 kg inclusive
- Female participants with either non-childbearing potential or with childbearing potential who commit to remain abstinent or use acceptable contraceptive methods during the treatment period and until at least 6 months after the follow-up visit
- Women of childbearing potential must have a negative serum pregnancy test result at screening and Day 1
Exclusion Criteria:
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis
- History or suspicion of drugs of abuse addiction
- History or suspicion of alcohol addiction
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 17 weeks after the last dose of study drug
- Prior administration of gantenerumab
- Clinically significant abnormalities (as judged by the investigator) in laboratory test results (including complete blood count, chemistry panel, and urinalysis)
- Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gantenerumab G4
Participants will receive single dose of gantenerumab HCLF manufactured by G4 process on Day 1.
|
Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen).
Other Names:
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Experimental: Gantenerumab G3
Participants will receive single dose of gantenerumab HCLF manufactured by G3 process on Day 1.
|
Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Observed Plasma Concentration (Cmax) of Gantenerumab
Time Frame: Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85
|
Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85
|
Area Under the Plasma Concentration-Time Curve From Time Zero (Predose) to Extrapolated Infinite Time (AUC 0-inf)
Time Frame: Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85
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Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Local Pain Assessments Using Visual Analog Scale (VAS)
Time Frame: After needle insertion, immediately postdose, 5 minutes (min), 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3
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After needle insertion, immediately postdose, 5 minutes (min), 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3
|
Local Pain Assessments Using Verbal Rating Scale (VRS)
Time Frame: After needle insertion, immediately postdose, 5 min, 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3
|
After needle insertion, immediately postdose, 5 min, 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3
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Skin Reactivity Assessment: Percentage of Participants by Severity of Injection Site Reactions
Time Frame: Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3
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Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3
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Skin Reactivity Assessment: Percentage of Participants by Size of Injection Site Reactions
Time Frame: Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3
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Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3
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Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time Frame: AEs: From Day 1 to Day 85; SAEs: From signing informed consent to end of study (maximum up to 5 months)
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AEs: From Day 1 to Day 85; SAEs: From signing informed consent to end of study (maximum up to 5 months)
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Percentage of Participants With Anti-Gantenerumab Antibodies
Time Frame: Predose (any time before injection) on Day 1 and on Day 85
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Predose (any time before injection) on Day 1 and on Day 85
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2017
Primary Completion (Actual)
December 15, 2017
Study Completion (Actual)
December 15, 2017
Study Registration Dates
First Submitted
July 31, 2017
First Submitted That Met QC Criteria
July 31, 2017
First Posted (Actual)
August 2, 2017
Study Record Updates
Last Update Posted (Actual)
December 12, 2018
Last Update Submitted That Met QC Criteria
December 11, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- WP40052
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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