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

Healthy Volunteer Clinical Trial

Official title:

A Multi-center, Randomized Open-label, Single-dose, Parallel Group Investigation of the Relative Bioavailability, Tolerability and Dose-exposure Relationship of a High Concentration Liquid Formulation (HCLF) Versus a Lyophilized Formulation (LyoF) of RO4909832 (Gantenerumab) When Administered by su

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636531
• Other study ID #: WP27951
• Secondary ID: 2011-006093-65
• Status: Completed
• Phase: Phase 1
• First received: July 6, 2012
• Last updated: November 1, 2016
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: AFSSAPS - Agence française de sécurité sanitaire des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• 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. 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

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• gantenerumab
High concentration liquid formulation (HCLF), single dose sc
• gantenerumab
Lyophilized formulation (LyoF), single dose sc

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative bioavailability: Area under the concentration-time curve		Pre-dose and up to 85 days post-dose	No
Secondary	Safety: Incidence of adverse events		approximately 8 months	No
Secondary	Dose-exposure relationship		approximately 8 months	No