A Study of A High Concentration Liquid Formulation Versus A Lyophilized Formulation of Gantenerumab in Healthy Volunteers

NCT01636531 | Completed Phase 1

• 2 other identifiers: WP279512011-006093-65
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This multi-center, randomized, open-label, single-dose, parallel group study will assess the relative bioavailability, tolerability and dose-exposure relationship of a high concentration liquid formulation (HCLF) versus a lyophilized formulation (LyoF) of gantenerumab (RO4909832) in healthy volunteers. Subjects will be randomized to receive single subcutaneous doses of either HCLF or LyoF. Anticipated time for treatment period and follow-up will be 13 weeks.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Relative bioavailability: Area under the concentration-time curve

  Pre-dose and up to 85 days post-dose

Secondary Outcomes (2)

• Safety: Incidence of adverse events

  approximately 8 months

• Dose-exposure relationship

  approximately 8 months

Study Arms (2)

HCLF

EXPERIMENTAL

Drug: gantenerumab

LyoF

ACTIVE COMPARATOR

Drug: gantenerumab

Interventions

gantenerumab DRUG

High concentration liquid formulation (HCLF), single dose sc

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. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
• Body mass index 18.0 to 30.0 kg/m2 inclusive
• Female subjects who are either surgically sterilized or post-menopausal
• 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 of abuse addiction
• Positive for hepatitis B, hepatitis C or HIV 1 or 2 infection
• Participation in an investigational drug or device study within three months before dosing
• Concomitant disease or condition or treatment which could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
• Any clinically relevant history of hypersensitivity or allergic reactions, either spontaneous or following drug administration or exposure to food or environmental agents
• Any familial history of early onset Alzheimer's disease
• Claustrophobia, presence of pacemakers, aneurism 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

Rennes, 35042, France

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
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 10, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (1)