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A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT02882009
Collaborator
(none)
48
Enrollment
1
Location
1
Arm
6.7
Actual Duration (Months)
7.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this randomized, open-label, parallel-group, placebo-controlled study is to assess pain following subcutaneous (SC) administration of gantenerumab as a high-concentration liquid formulation (HCLF) at different injection speeds. The total duration of the study for each healthy participant will be up to approximately 21 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-Center, Randomized, Open-Label, Parallel-Group, Placebo-Controlled, Cross-Over Study To Investigate the Impact of Speed of Injection and Site of Injection on Pain, Tolerability, Safety, and Pharmacokinetics Following Subcutaneous Administration of Gantenerumab in Healthy Volunteers
Actual Study Start Date :
Aug 31, 2016
Actual Primary Completion Date :
Mar 22, 2017
Actual Study Completion Date :
Mar 22, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gantenerumab + Placebo

Participants will be randomized to receive gantenerumab HCLF and placebo solution via SC injection according to different sequences for the site of administration and different injection speeds.

Drug: Gantenerumab
Gantenerumab as a HCLF will be administered via SC injection according to assigned treatment sequence.
Other Names:
  • RO4909832

    • Drug: Placebo
    Gantenerumab Placebo solution will be administered via SC injection according to assigned treatment sequence.

    Outcome Measures

    Primary Outcome Measures

    1. Local Pain as Assessed Using Visual Analog Scale (VAS) [Immediately after the injection on Day 1]

    Secondary Outcome Measures

    1. Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Gantenerumab [0 hour (predose) and 6, 12, and 24 hours postdose on Day 1, on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 43, 64, 85]

    2. Area Under the VAS Pain-Time Curve From Time 0 to 20 Minutes (AUC[0-20]) [0 to 20 minutes after injection on Day 1]

    3. Local Pain as Assessed Using Verbal Rating Scale (VRS) Score [Immediately after the injection on Day 1]

    4. Number of Participants With Skin Reactivity, as Assessed Using a 0 (No Reactivity) to 3 (Severe Reactivity) Scale [Immediately post-dose to 6 hours on Day 1]

    5. Number of Participants With Adverse Events [From Screening to Day 85]

    6. Number of Participants With Anti-Gantenerumab Antibodies (ADAs) [Day 1 (predose [Hour 0]) and Day 85]

    7. Maximum Observed Plasma Concentration (Cmax) of Gantenerumab [0 hour (predose) and 6, 12, and 24 hours postdose on Day 1, on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 43, 64, 85]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy male and female participants (healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram, hematology, blood chemistry, coagulation, serology, and urinalysis)

    • Body mass index between 18.0 and 30.0 kilograms per meter squared (kg/m^2), inclusive

    • Female participants of childbearing potential must commit to use two acceptable forms of contraception during the study and until at least 6 months after the follow-up visit

    Exclusion Criteria:

    • History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis

    • History or suspicion of drugs of abuse or alcohol addiction

    • Smokers who smoke more than 10 cigarettes per day or equivalent amount of tobacco as determined by history

    • Pregnant or lactating women

    • Positive result on hepatitis B virus (HBV), hepatitis C virus (HCV), or Human immunodeficiency virus (HIV)-1 and -2

    • Any familial history of early onset Alzheimer's disease

    • Prior administration of gantenerumab

    • Participation in an investigational drug medicinal product or medical device study within 90 days before dosing or within seven times the elimination half-life, whichever is longer

    • Any abnormal skin conditions or potentially obscuring tattoos, pigmentation, or lesions in the area intended for SC injection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PRA International Clinical Pharmacology Center (EDS US Clinic) Lenexa Kansas United States 66219

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02882009
    Other Study ID Numbers:
    • WP39322
    First Posted:
    Aug 29, 2016
    Last Update Posted:
    Jun 11, 2019
    Last Verified:
    Jun 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 11, 2019