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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT03236844
Collaborator
(none)
114
Enrollment
3
Locations
2
Arms
4.5
Actual Duration (Months)
38
Patients Per Site
8.5
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Aug 1, 2017
Actual Primary Completion Date :
Dec 15, 2017
Actual Study Completion Date :
Dec 15, 2017

Arms and Interventions

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 Names:
  • 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 Names:
  • RO4909832

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Observed Plasma Concentration (Cmax) of Gantenerumab [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) [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) [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) [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 [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 [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) [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 [Predose (any time before injection) on Day 1 and on Day 85]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 PRA International Clinical Pharmacology Center (EDS US Clinic) Lenexa Kansas United States 66219
    2 PRA Marlton New Jersey United States 08053
    3 PRA Health Sciences Salt Lake City Utah United States 84106

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT03236844
    Other Study ID Numbers:
    • WP40052
    First Posted:
    Aug 2, 2017
    Last Update Posted:
    Dec 12, 2018
    Last Verified:
    Dec 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 12, 2018