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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of gantenerumab
Time Frame: Up to 13 weeks
Up to 13 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: Approximately 21 weeks
Approximately 21 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 7, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (Estimate)

May 8, 2014

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP29113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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