A Study Investigating the Bioavailability of a High Concentration Liquid Formulation Versus a Reference Lyophilized Formulation of Gantenerumab in Healthy Volunteers

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT02133937

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This single-center, randomized open-label, single-dose, parallel group study will investigate the relative bioavailability of a high concentration liquid formulation (HCLF) versus the reference lyophilized formulation (LyoF) of gantenerumab. Healthy volunteers will be randomized 1:1 to receive single-dose gantenerumab by subcutaneous injection.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: gantenerumab Drug: gantenerumab	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Single-center, Randomized Open-label, Single-dose, Parallel Group Study to Investigate the Relative Bioavailability of a High Concentration Liquid Formulation (Hclf) in Prefilled Syringes Versus the Reference Lyophilized Formulation (Lyof) of Gantenerumab Following Administration by Subcutaneous Injection in Healthy Volunteers

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High Concentration Liquid Formulation (HCLF)	Drug: gantenerumab Single subcutaneous injection of a high concentration liquid formulation
Active Comparator: Lyophilized formulation	Drug: gantenerumab Single subcutaneous injection of a lyophilized formulation

Arm

Intervention/Treatment

Experimental: High Concentration Liquid Formulation (HCLF)

Drug: gantenerumab

Single subcutaneous injection of a high concentration liquid formulation

Active Comparator: Lyophilized formulation

Drug: gantenerumab

Single subcutaneous injection of a lyophilized formulation

Outcome Measures

Primary Outcome Measures

Plasma concentration of gantenerumab [Up to 13 weeks]

Secondary Outcome Measures

Incidence of adverse events [Approximately 21 weeks]

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 inclusive. Healthy status is defined by absence of evidence any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, coagulation, serology and urinalysis. Some medical conditions are allowed that are well controlled by single stable medication
A BMI between 18.0 to 30.0 kg/m2 inclusive
Use of highly effective contraception until 6 months after study follow-up visit
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 abuse addiction using DSM IV criteria
Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day), tobacco users and subjects on nicotine replacement therapy
Prior administration of gantenerumab
Participation in an investigational drug or device study within 60 days before dosing
Donation of blood over 500 mL within three months before dosing
Pregnancy or breast-feeding
Any abnormal skin conditions or potentially obscuring tattoos, pigmentation or lesions in the area intended for subcutaneous injection
Any familial history of early onset Alzheimer's disease
Claustrophobia, presence of pacemakers, aneurysm 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		Lenexa	Kansas	United States	66219

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:

NCT02133937

Other Study ID Numbers:

BP29113

First Posted:

May 8, 2014

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