Parkinson's Disease (PD)Phase 1NCT03033498
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease
A Phase 1 study testing ABBV-951 in people with Parkinson's Disease (PD), run by AbbVie at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- ABBV-951
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 7 sitesUnited States
- Study dates
- 17 May 2017to 8 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Parexel Baltimore /ID# 169255
Baltimore, Maryland, 21225
QUEST Research Institute /ID# 166035
Farmington Hills, Michigan, 48334-2977
Glendale Adventist Medical Ctr /ID# 166512
Glendale, California, 91206
Acpru /Id# 154976
Grayslake, Illinois, 60030
University of Kentucky Chandler Medical Center /ID# 169086
Lexington, Kentucky, 40536
Bioclinica Research - Orlando /ID# 169687
Orlando, Florida, 32806
Carolina Phase I, LLC /ID# 166034
Raleigh, North Carolina, 27612
About this study
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
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.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- ABBV-951
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-951Drug
ABBV-951 administered by subcutaneous infusion.
| Study group | Role | What they receive |
|---|---|---|
| ABBV-951 Dose 1 | Experimental | Participants will receive dose 1 of ABBV-951. Receives: Drug: ABBV-951 |
| ABBV-951 Dose 2 | Experimental | Participants will receive dose 2 of ABBV-951. Receives: Drug: ABBV-951 |
| ABBV-951 Dose 3 | Experimental | Participants will receive dose 3 of ABBV-951. Receives: Drug: ABBV-951 |
| ABBV-951 Dose 4 | Experimental | Participants will receive dose 4 of ABBV-951. Receives: Drug: ABBV-951 |
| ABBV-951 Dose 5 | Experimental | Participants will receive dose 5 of ABBV-951. Receives: Drug: ABBV-951 |
| ABBV-951 Dose 6 | Experimental | Participants will receive dose 6 of ABBV-951. Receives: Drug: ABBV-951 |
| ABBV-951 Dose 7 | Experimental | Participants will receive dose 7 of ABBV-951. Receives: Drug: ABBV-951 |
| ABBV-951 Dose 8 | Experimental | Participants will receive dose 8 of ABBV-951. Receives: Drug: ABBV-951 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Levodopa
Maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.
Measured: 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.
Measured: 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.
Measured: Hour 0-24
Adverse Events
Number of participants reporting adverse events
Measured: 24 hours
Terminal phase elimination rate constant (β)
Apparent terminal phase elimination rate constant (β or Beta)
Measured: Up to 72 hours
Terminal phase elimination half-life (T1/2)
Terminal phase elimination half-life (t1/2) will be assessed.
Measured: Up to 72 hours
Secondary outcomes (1)
Corrected QT (QTc) Interval
QT interval adjusted for heart rate.
Measured: Up to 76 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start17 May 2017
- Primary completion8 Jun 2019
- Study completion8 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033498
- Sponsor's protocol ID
- M15-738
- Status last verified
- Nov 2024
- First submitted
- 25 Jan 2017
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03033498
- Acronym / sponsor ID
- M15-738
- Conditions
- Parkinson's Disease (PD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 17 May 2017 (actual)
- Primary completion
- 8 Jun 2019 (actual)
- Study completion
- 8 Jun 2019 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| ABBV-951 Dose 1 | Experimental | Drug: ABBV-951Participants will receive dose 1 of ABBV-951. |
| ABBV-951 Dose 2 | Experimental | Drug: ABBV-951Participants will receive dose 2 of ABBV-951. |
| ABBV-951 Dose 3 | Experimental | Drug: ABBV-951Participants will receive dose 3 of ABBV-951. |
| ABBV-951 Dose 4 | Experimental | Drug: ABBV-951Participants will receive dose 4 of ABBV-951. |
| ABBV-951 Dose 5 | Experimental | Drug: ABBV-951Participants will receive dose 5 of ABBV-951. |
| ABBV-951 Dose 6 | Experimental | Drug: ABBV-951Participants will receive dose 6 of ABBV-951. |
| ABBV-951 Dose 7 | Experimental | Drug: ABBV-951Participants will receive dose 7 of ABBV-951. |
| ABBV-951 Dose 8 | Experimental | Drug: ABBV-951Participants will receive dose 8 of ABBV-951. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-951ABBV-951 administered by subcutaneous infusion. | Drug | 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 |
Primary outcome
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.
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.
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.
Adverse Events
Time frame: 24 hours
Number of participants reporting adverse events
Terminal phase elimination rate constant (β)
Time frame: Up to 72 hours
Apparent terminal phase elimination rate constant (β or Beta)
Terminal phase elimination half-life (T1/2)
Time frame: Up to 72 hours
Terminal phase elimination half-life (t1/2) will be assessed.
1 secondary outcome
Corrected QT (QTc) Interval
Time frame: Up to 76 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-951 in people with Parkinson's Disease (PD), run by AbbVie at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of Levodopa (time frame: Hour 0-24). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.