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

NCT02133937 | Completed Phase 1

• 1 other identifier: BP29113
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of gantenerumab

  Up to 13 weeks

Secondary Outcomes (1)

• Incidence of adverse events

  Approximately 21 weeks

Study Arms (2)

High Concentration Liquid Formulation (HCLF)

EXPERIMENTAL

Drug: gantenerumab

Lyophilized formulation

ACTIVE COMPARATOR

Drug: gantenerumab

Interventions

gantenerumab DRUG

Single subcutaneous injection of a high concentration liquid formulation

High Concentration Liquid Formulation (HCLF)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

gantenerumab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 8, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)