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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT01636531

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

23.9

Patients Per Site Per Month

Study Details

Study Description

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 Drug: gantenerumab	Phase 1

Study Design

Study Type:

Interventional

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 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Relative bioavailability: Area under the concentration-time curve [Pre-dose and up to 85 days post-dose]

Secondary Outcome Measures

Safety: Incidence of adverse events [approximately 8 months]
Dose-exposure relationship [approximately 8 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Rennes		France	35042

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01636531

Other Study ID Numbers:

WP27951
2011-006093-65

First Posted:

Jul 10, 2012

Last Update Posted:

Nov 2, 2016

Last Verified:

Nov 1, 2016

Additional relevant MeSH terms:

Antibodies, Monoclonal

Study Results

No Results Posted as of Nov 2, 2016