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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

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ClinicalTrials.gov Identifier: NCT02882009
Recruitment Status : Completed
First Posted : August 29, 2016
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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
Healthy Volunteer Drug: Gantenerumab Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
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 : August 31, 2016
Actual Primary Completion Date : March 22, 2017
Actual Study Completion Date : March 22, 2017
Arms and Interventions
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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 Name: RO4909832

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


Outcome Measures
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Primary Outcome Measures :
  1. Local Pain as Assessed Using Visual Analog Scale (VAS) [ Time Frame: 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 [ Time Frame: 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]) [ Time Frame: 0 to 20 minutes after injection on Day 1 ]
  3. Local Pain as Assessed Using Verbal Rating Scale (VRS) Score [ Time Frame: 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 [ Time Frame: Immediately post-dose to 6 hours on Day 1 ]
  5. Number of Participants With Adverse Events [ Time Frame: From Screening to Day 85 ]
  6. Number of Participants With Anti-Gantenerumab Antibodies (ADAs) [ Time Frame: Day 1 (predose [Hour 0]) and Day 85 ]
  7. Maximum Observed Plasma Concentration (Cmax) of Gantenerumab [ Time Frame: 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
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882009


Locations
United States, Kansas
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
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02882009     History of Changes
Other Study ID Numbers: WP39322
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs