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Relative Bioavailability of Gantenerumab Produced by G4 Process Versus G3 Process Following Subcutaneous (SC) Injection in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03236844
Recruitment Status : Completed
First Posted : August 2, 2017
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: Gantenerumab Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : December 15, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Gantenerumab G4
Participants will receive single dose of gantenerumab HCLF manufactured by G4 process on Day 1.
 Drug: Gantenerumab
Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen).
Other Name: RO4909832
Experimental: Gantenerumab G3
Participants will receive single dose of gantenerumab HCLF manufactured by G3 process on Day 1.
 Drug: Gantenerumab
Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen).
Other Name: RO4909832


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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) ]
  6. Percentage of Participants With Anti-Gantenerumab Antibodies [ Time Frame: Predose (any time before injection) on Day 1 and on Day 85 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236844


Locations
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United States, Kansas
PRA International Clinical Pharmacology Center (EDS US Clinic)
Lenexa, Kansas, United States, 66219
United States, New Jersey
PRA
Marlton, New Jersey, United States, 08053
United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03236844    
Other Study ID Numbers: WP40052
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No