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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03033498
• Date of registration: 25/01/2017
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease
• Scientific 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
• Date of first enrolment: May 17, 2017
• Target sample size: 29
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03033498
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion 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.



Age minimum: 45 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease (PD)

Intervention(s)

Drug: ABBV-951

Primary Outcome(s)

Terminal phase elimination half-life (T1/2) [Time Frame: Up to 72 hours]

Adverse Events [Time Frame: 24 hours]

Terminal phase elimination rate constant (ß) [Time Frame: Up to 72 hours]

Area Under the Plasma Concentration-Time Curve (AUC) of Levodopa [Time Frame: Hour 0-24]

Maximum Observed Plasma Concentration (Cmax) of Levodopa [Time Frame: Hour 0-24]

Time to maximum observed plasma concentration (Tmax) of Levodopa [Time Frame: Hour 0-24]

Secondary Outcome(s)

Corrected QT (QTc) Interval [Time Frame: Up to 76 hours]

Secondary ID(s)

M15-738

Source(s) of Monetary Support

Please refer to primary and secondary sponsors