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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: gantenerumab

• Registration Number: NCT02133937
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-08
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Concentration Liquid Formulation (HCLF)	gantenerumab	-
Lyophilized formulation	gantenerumab	-

Primary Outcome Measures

Name	Time	Method
Plasma concentration of gantenerumab	Up to 13 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	Approximately 21 weeks