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

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: gantenerumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02133937

BP29113

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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