A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease

Parkinson's Disease (PD) Clinical Trial

Official title:

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 24 Hour and 72 Hour Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033498
• Other study ID #: M15-738
• Status: Completed
• Phase: Phase 1
• Start date: May 17, 2017
• Est. completion date: June 8, 2019

Study information

• Verified date: November 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the safety, tolerability, and pharmacokinetics of single, ascending doses of ABBV-951 administered as a subcutaneous bolus infusion followed by a continuous subcutaneous infusion in subjects with Parkinson's disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 8, 2019
• Est. primary completion date: June 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subject has a diagnosis of definite idiopathic PD, which is LD responsive, according to the United Kingdom Parkinson's Disease Society Brain Bank Criteria.

• Subject must be taking an optimized and stable regimen of oral medications for PD, which has remained stable and unchanged for at least 30 days before dosing in this study. This regimen must include oral carbidopa/levodopa (CD/LD) tablets (e.g., Sinemet).

• Females must have negative results for pregnancy tests at screening and prior to confinement.

• If male, subject must be surgically sterile or practicing an adequate method of birth control from initial study drug administration until 30 days after last dose of study drug.

• Body Mass Index (BMI) is 18.0 to 38.0, inclusive.

• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

• Receipt of any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration.

• History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations that in the Investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.

• Use of any medication from the prohibited concomitant therapies.

• Subjects with glomerular filtration rate (GFR) less than 45 ml/min/1.73 m2 as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation.

• Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to initial study drug administration.

• Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive ABBV-951.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease (PD)

Intervention

Drug:
• ABBV-951
ABBV-951 administered by subcutaneous infusion.

Locations

Country	Name	City	State
United States	Parexel Baltimore /ID# 169255	Baltimore	Maryland
United States	QUEST Research Institute /ID# 166035	Farmington Hills	Michigan
United States	Glendale Adventist Medical Ctr /ID# 166512	Glendale	California
United States	Acpru /Id# 154976	Grayslake	Illinois
United States	University of Kentucky Chandler Medical Center /ID# 169086	Lexington	Kentucky
United States	Bioclinica Research - Orlando /ID# 169687	Orlando	Florida
United States	Carolina Phase I, LLC /ID# 166034	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of Levodopa	Maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.	Hour 0-24
Primary	Time to maximum observed plasma concentration (Tmax) of Levodopa	Time to maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.	Hour 0-24
Primary	Area Under the Plasma Concentration-Time Curve (AUC) of Levodopa	Area under the plasma concentration-time curve following a single infusion of ABBV-951.	Hour 0-24
Primary	Adverse Events	Number of participants reporting adverse events	24 hours
Primary	Terminal phase elimination rate constant (ß)	Apparent terminal phase elimination rate constant (ß or Beta)	Up to 72 hours
Primary	Terminal phase elimination half-life (T1/2)	Terminal phase elimination half-life (t1/2) will be assessed.	Up to 72 hours
Secondary	Corrected QT (QTc) Interval	QT interval adjusted for heart rate.	Up to 76 hours