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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease (PD)
• Intervention / Treatment: Drug: ABBV-951

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Glendale Adventist Medical Ctr /ID# 166512
  • Florida
    • Orlando, Florida, United States, 32806
      • Bioclinica Research - Orlando /ID# 169687
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 154976
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center /ID# 169086
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Parexel Baltimore /ID# 169255
  • Michigan
    • Farmington Hills, Michigan, United States, 48334-2977
      • QUEST Research Institute /ID# 166035
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Carolina Phase I, LLC /ID# 166034

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABBV-951 Dose 1; Participants will receive dose 1 of ABBV-951.	Drug: ABBV-951; ABBV-951 administered by subcutaneous infusion.
Experimental: ABBV-951 Dose 2; Participants will receive dose 2 of ABBV-951.	Drug: ABBV-951; ABBV-951 administered by subcutaneous infusion.
Experimental: ABBV-951 Dose 3; Participants will receive dose 3 of ABBV-951.	Drug: ABBV-951; ABBV-951 administered by subcutaneous infusion.
Experimental: ABBV-951 Dose 4; Participants will receive dose 4 of ABBV-951.	Drug: ABBV-951; ABBV-951 administered by subcutaneous infusion.
Experimental: ABBV-951 Dose 5; Participants will receive dose 5 of ABBV-951.	Drug: ABBV-951; ABBV-951 administered by subcutaneous infusion.
Experimental: ABBV-951 Dose 6; Participants will receive dose 6 of ABBV-951.	Drug: ABBV-951; ABBV-951 administered by subcutaneous infusion.
Experimental: ABBV-951 Dose 7; Participants will receive dose 7 of ABBV-951.	Drug: ABBV-951; ABBV-951 administered by subcutaneous infusion.
Experimental: ABBV-951 Dose 8; Participants will receive dose 8 of ABBV-951.	Drug: ABBV-951; ABBV-951 administered by subcutaneous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of Levodopa	Maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.	Hour 0-24
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
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
Adverse Events	Number of participants reporting adverse events	24 hours
Terminal phase elimination rate constant (β)	Apparent terminal phase elimination rate constant (β or Beta)	Up to 72 hours
Terminal phase elimination half-life (T1/2)	Terminal phase elimination half-life (t1/2) will be assessed.	Up to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected QT (QTc) Interval	QT interval adjusted for heart rate.	Up to 76 hours

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): June 8, 2019
• Study Completion (Actual): June 8, 2019

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: M15-738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No