Rennes, 35042, France
NCT Number: NCT01636531
A Study of A High Concentration Liquid Formulation Versus A Lyophilized Formulation of Gantenerumab in Healthy Volunteers
This multi-center, randomized, open-label, single-dose, parallel group study will assess the relative bioavailability, tolerability and dose-exposure relationship of a high concentration liquid formulation (HCLF) versus a lyophilized formulation (LyoF) of gantenerumab (RO4909832) in healthy volunteers. Subjects will be randomized to receive single subcutaneous doses of either HCLF or LyoF. Anticipated time for treatment period and follow-up will be 13 weeks.
Looking for future studies?
Notify MeKey information
Conditions
Age range
40 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy male and female subjects, 40 to 70 years of age. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- Body mass index 18.0 to 30.0 kg/m2 inclusive
- Female subjects who are either surgically sterilized or post-menopausal
- Agree not to donate blood or blood products for transfusion for the duration of the study and for one year after their dosing
Exclusion criteria
- Suspicion of alcohol or drugs of abuse addiction
- Positive for hepatitis B, hepatitis C or HIV 1 or 2 infection
- Participation in an investigational drug or device study within three months before dosing
- Concomitant disease or condition or treatment which could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- Any clinically relevant history of hypersensitivity or allergic reactions, either spontaneous or following drug administration or exposure to food or environmental agents
- Any familial history of early onset Alzheimer's disease
- Claustrophobia, presence of pacemakers, aneurism clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would contraindicate an MRI scan
Treatment and study plan
gantenerumab
DrugHigh concentration liquid formulation (HCLF), single dose sc
Primary outcomes
-
Relative bioavailability: Area under the concentration-time curve
Time frame: Pre-dose and up to 85 days post-dose
Secondary outcomes
-
Safety: Incidence of adverse events
Time frame: approximately 8 months
-
Dose-exposure relationship
Time frame: approximately 8 months
Sponsors and collaborators
Lead sponsor
Hoffmann-La Roche
Industry
Registry information
Official study title
A Multi-center, Randomized Open-label, Single-dose, Parallel Group Investigation of the Relative Bioavailability, Tolerability and Dose-exposure Relationship of a High Concentration Liquid Formulation (HCLF) Versus a Lyophilized Formulation (LyoF) of RO4909832 (Gantenerumab) When Administered by su
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Jul 10, 2012
- Registry last updated
- Nov 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
A Phase 1 Study to Assess the Effect of ABBV-722 on Ethinyl Estradiol and Levonorgestrel Drug Levels in Healthy Adult Female Participants
NCT07502417
Healthy Volunteer
Grayslake, Illinois, United States
View Trial DetailsLinks Between Inflammation and Cardiometabolic Diseases
NCT01934660
Cardiovascular Disease, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial DetailsA Single and Multiple Ascending Doses, Relative Bioavailability, Food Effect, and Drug-Drug Interaction Study of NX-5948 in Healthy Volunteers
NCT06717269
Healthy Volunteer
Lincoln, Nebraska, United States
View Trial DetailsDiagnosis and History Study of Patients With Different Neurological Conditions
NCT00001367
Healthy Volunteer, Nervous System Disease
Bethesda, Maryland, United States
View Trial Details