Skip to main content
OpenTrials
Completed

NCT Number: NCT02882009

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA International Clinical Pharmacology Center (EDS US Clinic)

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

gantenerumab

Drug

Gantenerumab as a HCLF will be administered via SC injection according to assigned treatment sequence.

Other names: RO4909832

Placebo

Drug

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

Primary outcomes

  1. Local Pain as Assessed Using Visual Analog Scale (VAS)

    Time frame: Immediately after the injection on Day 1

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 29, 2016
Registry last updated
Jun 11, 2019

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.