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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 31, 2017
First Posted Date  ICMJE August 2, 2017
Last Update Posted Date December 12, 2018
Actual Study Start Date  ICMJE August 1, 2017
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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) ]
  • Percentage of Participants With Anti-Gantenerumab Antibodies [ Time Frame: Predose (any time before injection) on Day 1 and on Day 85 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relative Bioavailability of Gantenerumab Produced by G4 Process Versus G3 Process Following Subcutaneous (SC) Injection in Healthy Participants
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy Participants
Intervention  ICMJE Drug: Gantenerumab
Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen).
Other Name: RO4909832
Study Arms  ICMJE
  • Experimental: Gantenerumab G4
    Participants will receive single dose of gantenerumab HCLF manufactured by G4 process on Day 1.
    Intervention: Drug: Gantenerumab
  • Experimental: Gantenerumab G3
    Participants will receive single dose of gantenerumab HCLF manufactured by G3 process on Day 1.
    Intervention: Drug: Gantenerumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2017)
114
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 15, 2017
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03236844
Other Study ID Numbers  ICMJE WP40052
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP