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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

Primary Purpose

Parkinson's Disease (PD)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ABBV-951

About this trial

This is an interventional treatment trial for Parkinson's Disease (PD)

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Glendale Adventist Medical Ctr /ID# 166512
Bioclinica Research - Orlando /ID# 169687
Acpru /Id# 154976
University of Kentucky Chandler Medical Center /ID# 169086
Parexel Baltimore /ID# 169255
QUEST Research Institute /ID# 166035
Carolina Phase I, LLC /ID# 166034

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

ABBV-951 Dose 1

ABBV-951 Dose 2

ABBV-951 Dose 3

ABBV-951 Dose 4

ABBV-951 Dose 5

ABBV-951 Dose 6

ABBV-951 Dose 7

ABBV-951 Dose 8

Arm Description

Participants will receive dose 1 of ABBV-951.

Participants will receive dose 2 of ABBV-951.

Participants will receive dose 3 of ABBV-951.

Participants will receive dose 4 of ABBV-951.

Participants will receive dose 5 of ABBV-951.

Participants will receive dose 6 of ABBV-951.

Participants will receive dose 7 of ABBV-951.

Participants will receive dose 8 of ABBV-951.

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of Levodopa

Maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.

Time to maximum observed plasma concentration (Tmax) of Levodopa

Time to maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.

Area Under the Plasma Concentration-Time Curve (AUC) of Levodopa

Area under the plasma concentration-time curve following a single infusion of ABBV-951.

Adverse Events

Number of participants reporting adverse events

Terminal phase elimination rate constant (β)

Apparent terminal phase elimination rate constant (β or Beta)

Terminal phase elimination half-life (T1/2)

Terminal phase elimination half-life (t1/2) will be assessed.

Secondary Outcome Measures

Corrected QT (QTc) Interval

QT interval adjusted for heart rate.

Full Information

NCT ID

NCT03033498

First Posted

January 25, 2017

Last Updated

November 13, 2019

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT03033498

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

May 17, 2017 (Actual)

Primary Completion Date

June 8, 2019 (Actual)

Study Completion Date

June 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease (PD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABBV-951 Dose 1

Arm Type

Experimental

Arm Description

Participants will receive dose 1 of ABBV-951.

Arm Title

ABBV-951 Dose 2

Arm Type

Experimental

Arm Description

Participants will receive dose 2 of ABBV-951.

Arm Title

ABBV-951 Dose 3

Arm Type

Experimental

Arm Description

Participants will receive dose 3 of ABBV-951.

Arm Title

ABBV-951 Dose 4

Arm Type

Experimental

Arm Description

Participants will receive dose 4 of ABBV-951.

Arm Title

ABBV-951 Dose 5

Arm Type

Experimental

Arm Description

Participants will receive dose 5 of ABBV-951.

Arm Title

ABBV-951 Dose 6

Arm Type

Experimental

Arm Description

Participants will receive dose 6 of ABBV-951.

Arm Title

ABBV-951 Dose 7

Arm Type

Experimental

Arm Description

Participants will receive dose 7 of ABBV-951.

Arm Title

ABBV-951 Dose 8

Arm Type

Experimental

Arm Description

Participants will receive dose 8 of ABBV-951.

Intervention Type

Drug

Intervention Name(s)

ABBV-951

Intervention Description

ABBV-951 administered by subcutaneous infusion.

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax) of Levodopa

Description

Maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.

Time Frame

Hour 0-24

Title

Time to maximum observed plasma concentration (Tmax) of Levodopa

Description

Time to maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.

Time Frame

Hour 0-24

Title

Area Under the Plasma Concentration-Time Curve (AUC) of Levodopa

Description

Area under the plasma concentration-time curve following a single infusion of ABBV-951.

Time Frame

Hour 0-24

Title

Adverse Events

Description

Number of participants reporting adverse events

Time Frame

24 hours

Title

Terminal phase elimination rate constant (β)

Description

Apparent terminal phase elimination rate constant (β or Beta)

Time Frame

Up to 72 hours

Title

Terminal phase elimination half-life (T1/2)

Description

Terminal phase elimination half-life (t1/2) will be assessed.

Time Frame

Up to 72 hours

Secondary Outcome Measure Information:

Title

Corrected QT (QTc) Interval

Description

QT interval adjusted for heart rate.

Time Frame

Up to 76 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Glendale Adventist Medical Ctr /ID# 166512

City

Glendale

State/Province

California

ZIP/Postal Code

91206

Country

United States

Facility Name

Bioclinica Research - Orlando /ID# 169687

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Acpru /Id# 154976

City

Grayslake

State/Province

Illinois

ZIP/Postal Code

60030

Country

United States

Facility Name

University of Kentucky Chandler Medical Center /ID# 169086

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Parexel Baltimore /ID# 169255

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21225

Country

United States

Facility Name

QUEST Research Institute /ID# 166035

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48334-2977

Country

United States

Facility Name

Carolina Phase I, LLC /ID# 166034

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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