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

NCT03236844 | Completed Phase 1 FDA Drug

• 1 other identifier: WP40052
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• 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

• 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

• 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

• 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

• 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)

Study Arms (2)

Gantenerumab G4

EXPERIMENTAL

Participants will receive single dose of gantenerumab HCLF manufactured by G4 process on Day 1.

Drug: Gantenerumab

Gantenerumab G3

EXPERIMENTAL

Participants will receive single dose of gantenerumab HCLF manufactured by G3 process on Day 1.

Drug: Gantenerumab

Interventions

Gantenerumab DRUG

Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen).

Also known as: RO4909832

Gantenerumab G3; Gantenerumab G4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

PRA International Clinical Pharmacology Center (EDS US Clinic)

Lenexa, Kansas, 66219, United States

Location

PRA

Marlton, New Jersey, 08053, United States

Location

PRA Health Sciences

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Interventions

gantenerumab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 2, 2017
• Study Start: August 1, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

US (3)