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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882009
• Other study ID #: WP39322
• Status: Completed
• Phase: Phase 1
• Start date: August 31, 2016
• Est. completion date: March 22, 2017

Study information

• Verified date: June 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 22, 2017
• Est. primary completion date: March 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

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

Locations

Country	Name	City	State
United States	PRA International Clinical Pharmacology Center (EDS US Clinic)	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Pain as Assessed Using Visual Analog Scale (VAS)		Immediately after the injection on Day 1
Secondary	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
Secondary	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
Secondary	Local Pain as Assessed Using Verbal Rating Scale (VRS) Score		Immediately after the injection on Day 1
Secondary	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
Secondary	Number of Participants With Adverse Events		From Screening to Day 85
Secondary	Number of Participants With Anti-Gantenerumab Antibodies (ADAs)		Day 1 (predose [Hour 0]) and Day 85
Secondary	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