Status:
COMPLETED
Relative Bioavailability of Gantenerumab Produced by G4 Process Versus G3 Process Following Subcutaneous (SC) Injection in Healthy Participants
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Participants
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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 g...
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2017
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT03236844
Start Date
August 1 2017
End Date
December 15 2017
Last Update
December 12 2018
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
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