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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01636531
First received: July 6, 2012
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
Drug: gantenerumab
Phase 1

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Relative bioavailability: Area under the concentration-time curve [ Time Frame: Pre-dose and up to 85 days post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 8 months ] [ Designated as safety issue: No ]
  • Dose-exposure relationship [ Time Frame: approximately 8 months ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: May 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HCLF Drug: gantenerumab
High concentration liquid formulation (HCLF), single dose sc
Active Comparator: LyoF Drug: gantenerumab
Lyophilized formulation (LyoF), single dose sc

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636531

Locations
France
Rennes, France, 35000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01636531     History of Changes
Other Study ID Numbers: WP27951, 2011-006093-65
Study First Received: July 6, 2012
Last Updated: May 7, 2013
Health Authority: France: AFSSAPS - Agence française de sécurité sanitaire des produits de santé

ClinicalTrials.gov processed this record on April 17, 2014