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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033498
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease (PD) Drug: ABBV-951 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : May 17, 2017
Actual Primary Completion Date : June 8, 2019
Actual Study Completion Date : June 8, 2019

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of Levodopa [ Time Frame: Hour 0-24 ]
    Maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.

  2. Time to maximum observed plasma concentration (Tmax) of Levodopa [ Time Frame: Hour 0-24 ]
    Time to maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.

  3. Area Under the Plasma Concentration-Time Curve (AUC) of Levodopa [ Time Frame: Hour 0-24 ]
    Area under the plasma concentration-time curve following a single infusion of ABBV-951.

  4. Adverse Events [ Time Frame: 24 hours ]
    Number of participants reporting adverse events

  5. Terminal phase elimination rate constant (β) [ Time Frame: Up to 72 hours ]
    Apparent terminal phase elimination rate constant (β or Beta)

  6. Terminal phase elimination half-life (T1/2) [ Time Frame: Up to 72 hours ]
    Terminal phase elimination half-life (t1/2) will be assessed.


Secondary Outcome Measures :
  1. Corrected QT (QTc) Interval [ Time Frame: Up to 76 hours ]
    QT interval adjusted for heart rate.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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): NCT03033498


Locations
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United States, California
Glendale Adventist Medical Ctr /ID# 166512
Glendale, California, United States, 91206
United States, Florida
Bioclinica Research - Orlando /ID# 169687
Orlando, Florida, United States, 32806
United States, Illinois
Acpru /Id# 154976
Grayslake, Illinois, United States, 60030
United States, Kentucky
University of Kentucky Chandler Medical Center /ID# 169086
Lexington, Kentucky, United States, 40536
United States, Maryland
Parexel Baltimore /ID# 169255
Baltimore, Maryland, United States, 21225
United States, Michigan
QUEST Research Institute /ID# 166035
Farmington Hills, Michigan, United States, 48334-2977
United States, North Carolina
Carolina Phase I, LLC /ID# 166034
Raleigh, North Carolina, United States, 27612
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03033498    
Other Study ID Numbers: M15-738
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases