A Study of A High Concentration Liquid Formulation Versus A Lyophilized Formulation of Gantenerumab in Healthy Volunteers

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. Identifier: NCT01636531
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: gantenerumab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official 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
Study Start Date : May 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Experimental: HCLF Drug: gantenerumab
High concentration liquid formulation (HCLF), single dose sc

Active Comparator: LyoF Drug: gantenerumab
Lyophilized formulation (LyoF), single dose sc

Primary Outcome Measures :
  1. Relative bioavailability: Area under the concentration-time curve [ Time Frame: Pre-dose and up to 85 days post-dose ]

Secondary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: approximately 8 months ]
  2. Dose-exposure relationship [ Time Frame: approximately 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01636531

Rennes, France, 35042
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01636531     History of Changes
Other Study ID Numbers: WP27951
2011-006093-65 ( EudraCT Number )
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs