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Completed

NCT Number: NCT03033498

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 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.

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Key information

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Glendale Adventist Medical Ctr /ID# 166512, Glendale, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

ABBV-951

Drug

ABBV-951 administered by subcutaneous infusion.

Primary outcomes

  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 outcomes

  1. Corrected QT (QTc) Interval

    Time frame: Up to 76 hours

    QT interval adjusted for heart rate.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 26, 2017
Registry last updated
Nov 12, 2024

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.

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