Skip to main content
OpenTrials
Completed

NCT Number: NCT01636531

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rennes, 35042, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gantenerumab

Drug

High concentration liquid formulation (HCLF), single dose sc

Primary outcomes

  1. Relative bioavailability: Area under the concentration-time curve

    Time frame: Pre-dose and up to 85 days post-dose

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 8 months

  2. Dose-exposure relationship

    Time frame: approximately 8 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 10, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.