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

NCT ID: NCT02133937

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-09-30

Brief Summary

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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

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Concentration Liquid Formulation (HCLF)

Group Type EXPERIMENTAL

gantenerumab

Intervention Type DRUG

Single subcutaneous injection of a high concentration liquid formulation

Lyophilized formulation

Group Type ACTIVE_COMPARATOR

gantenerumab

Intervention Type DRUG

Single subcutaneous injection of a lyophilized formulation

Interventions

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gantenerumab

Single subcutaneous injection of a high concentration liquid formulation

Intervention Type DRUG

gantenerumab

Single subcutaneous injection of a lyophilized formulation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Lenexa, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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BP29113

Identifier Type: -

Identifier Source: org_study_id