Parkinson's DiseasePhase 1NCT01500707
Single Dose Study to Assess the Pharmacokinetics of SCH 900800 in Subjects With Parkinson's Disease Being Treated With Levodopa (L-DOPA) (P08235)
A Phase 1 study testing SCH 900800 in people with Parkinson's Disease, run by Merck Sharp & Dohme LLC.
Trial summary
This study is being done to assess the pharmacokinetics of SCH 900800 in participants with moderate to severe Parkinson's Disease (PD) being treated with L-DOPA. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- SCH 900800
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jul 2013
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) between 18 and 35
- Diagnosis of idiopathic Parkinson's disease (PD) characterized by at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); participants must have either moderate severity PD or moderate to severe PD with motor fluctuations
- For participants with moderate PD, Hoehn and Yahr stage must be ≥1.5 and ≤4 in the "off" state at Screening; for participants with moderate to severe PD with motor fluctuations, Hoehn and Yahr stage must be ≥2 and ≤4 in the "on" state at Screening
- On stable anti-parkinson treatment regimen that includes L-DOPA/carbidopa for at least 3 weeks prior to screening and clinically stable at the time of randomization (predose), and first morning dose of L-DOPA must be 100 mg or greater
- L-DOPA therapy for ≥ 6 months prior to screening
- If taking adjunct PD medications (amantadine, anticholinergics, DOPA decarboxylase inhibitor, dopamine agonist, entacapone, rasagiline or selegiline) must be on stable dose for at least 4 weeks prior to randomization on this study
Show all 9Show fewer
- Females, if fertile, willing to use a medically acceptable method of contraception for 3 months prior to screening through 2 months after stopping study drug
- Non-vasectomized males must agree to use a condom with spermicide (when
- marketed in the country) or abstain from sexual intercourse during the trial and for 3 months after stopping the study drug
Who cannot join
- Pregnant or intending to become pregnant within 3 months of ending study therapy
- Breastfeeding
- Systolic blood pressure (BP) ≥150 mm Hg or diastolic BP ≥90 mm Hg at Screening and at a BP recheck prior to randomization. If antihypertensive medications are used to control BP, dose of antihypertensive medications must be stable for at least 2 weeks prior to randomization
- History of clinically significant cardiovascular disease or procedure prior to randomization, including, but not limited to, myocardial infarction, prolonged QT interval corrected for heart rate, other clinically important ECG abnormality, angioplasty, stable or unstable angina, or heart failure
- History of clinically significant or uncontrolled neurologic (other then Parkinson's disease) endocrine, gastrointestinal, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- Surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug including history or presence of inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding; history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; history of pancreatic injury or pancreatitis; history or presence of liver disease or liver injury; history or presence of impaired renal function as indicated by clinically significant elevation in creatinine, blood urea nitrogen (BUN)/urea, urinary albumin, or clinically significant urinary cellular constituents ; or history of urinary obstruction or difficulty in voiding
Show all 19Show fewer
- Infectious disease within 4 weeks prior to drug administration
- Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
- Clinically significant complications of Parkinson's disease or Parkinson's disease treatments, including severe, disabling motor fluctuations that do not allow the subject to maintain a stable L-DOPA/carbidopa dose; disabling dyskinesias; hallucinations; or dementia
- History of alcohol or drug abuse in the past 2 years
- Donation of blood in the past 60 days
- Previously received SCH 900800
- Currently participating in another clinical study or participated in a clinical study in which an investigational drug or surgical procedure was administered, within 30 days of baseline
- Study staff personnel or family members of the study staff personnel
- Use of more than 10 cigarettes or equivalent tobacco use per day
- History of malignancy
- A form of parkinsonism other than idiopathic Parkinson's disease (e.g., multiple system atrophy or progressive supranuclear palsy)
- Imminent risk of self-harm or of harm to others, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale. Exclude any participant reporting suicidal ideation with intent, with or without a plan in the past 2 months or suicidal behavior in the past 6 months
- Use of strong or moderate inhibitors or inducers of cytochrome P (CYP) 3A4 isoenzyme (e.g. St John's Wort, ketoconazole, ritonavir, rifampin, macrolide antibiotics, some calcium channel blockers including diltiazem, verapamil, etc.) within 30 days; inhibitors of enzyme CY2D6 within 14 days; Proton Pump Inhibitors or histamine (H2) Receptor Blockers within 14 days
About this study
Official title: A Single Dose Study to Assess the Pharmacokinetics of SCH 900800 Administered as Oral Tablets in L-DOPA-treated Subjects With Parkinson's Disease
This study is being done to assess the pharmacokinetics of SCH 900800 in participants with moderate to severe Parkinson's Disease (PD) being treated with L-DOPA.
- Conditions
- Parkinson's Disease
- Being tested
- SCH 900800
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 900800Drug
Also called MK-8800
SCH 900800, one 20 mg tablet, orally
| Study group | Role | What they receive |
|---|---|---|
| SCH 900800 | Experimental | Participants receiving a single dose of SCH 900800 Receives: Drug: SCH 900800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration time curve from Hour 0 to infinity (AUC0-∞) of SCH 900800
Measured: Hour 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 14, 32, 48, 72, and 96 hours post-dose
Maximum concentration (Cmax) of SCH 900800
Measured: Hour 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 14, 32, 48, 72, and 96 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study startJan 2013
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500707
- Sponsor's protocol ID
- P08235
- Status last verified
- Jan 2015
- First submitted
- 22 Dec 2011
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Study to Assess the Pharmacokinetics of SCH 900800 Administered as Oral Tablets in L-DOPA-treated Subjects With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01500707
- Acronym / sponsor ID
- P08235
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 28 Dec 2011 (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.
This study is being done to assess the pharmacokinetics of SCH 900800 in participants with moderate to severe Parkinson's Disease (PD) being treated with L-DOPA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCH 900800 | Experimental | Drug: SCH 900800Participants receiving a single dose of SCH 900800 |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Body Mass Index (BMI) between 18 and 35
- Diagnosis of idiopathic Parkinson's disease (PD) characterized by at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); participants must have either moderate severity PD or moderate to severe PD with motor fluctuations
- For participants with moderate PD, Hoehn and Yahr stage must be ≥1.5 and ≤4 in the "off" state at Screening; for participants with moderate to severe PD with motor fluctuations, Hoehn and Yahr stage must be ≥2 and ≤4 in the "on" state at Screening
- On stable anti-parkinson treatment regimen that includes L-DOPA/carbidopa for at least 3 weeks prior to screening and clinically stable at the time of randomization (predose), and first morning dose of L-DOPA must be 100 mg or greater
- L-DOPA therapy for ≥ 6 months prior to screening
Key exclusion criteria (19 listed)
- Pregnant or intending to become pregnant within 3 months of ending study therapy
- Breastfeeding
- Systolic blood pressure (BP) ≥150 mm Hg or diastolic BP ≥90 mm Hg at Screening and at a BP recheck prior to randomization. If antihypertensive medications are used to control BP, dose of antihypertensive medications must be stable for at least 2 weeks prior to randomization
- History of clinically significant cardiovascular disease or procedure prior to randomization, including, but not limited to, myocardial infarction, prolonged QT interval corrected for heart rate, other clinically important ECG abnormality, angioplasty, stable or unstable angina, or heart failure
- History of clinically significant or uncontrolled neurologic (other then Parkinson's disease) endocrine, gastrointestinal, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
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 |
|---|---|---|
| SCH 900800Also: MK-8800SCH 900800, one 20 mg tablet, orally | Drug | SCH 900800 |
Primary outcome
Area under the concentration time curve from Hour 0 to infinity (AUC0-∞) of SCH 900800
Time frame: Hour 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 14, 32, 48, 72, and 96 hours post-dose
Maximum concentration (Cmax) of SCH 900800
Time frame: Hour 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 14, 32, 48, 72, and 96 hours post-dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCH 900800 in people with Parkinson's Disease, run by Merck Sharp & Dohme LLC.
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 9 inclusion and 19 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: withdrawn, as of the sponsor's last update on 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Area under the concentration time curve from Hour 0 to infinity (AUC0-∞) of SCH 900800 (time frame: Hour 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 14, 32, 48, 72, and 96 hours post-dose). The study lists 2 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 8 Jan 2015.