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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133937
• Other study ID #: BP29113
• Status: Completed
• Phase: Phase 1
• First received: May 7, 2014
• Last updated: November 1, 2016
• Start date: April 2014
• Est. completion date: September 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• gantenerumab
Single subcutaneous injection of a high concentration liquid formulation
• gantenerumab
Single subcutaneous injection of a lyophilized formulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of gantenerumab		Up to 13 weeks	No
Secondary	Incidence of adverse events		Approximately 21 weeks	No