EUCTR2011-004438-32-DE
Active, not recruiting
Not Applicable
A randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC
GlaxoSmithKline Research and Development Limited0 sites70 target enrollmentAugust 13, 2013
ConditionsInvestigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism.MedDRA version: 16.1Level: PTClassification code 10051153Term: Diabetic gastroparesisSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism.
- Sponsor
- GlaxoSmithKline Research and Development Limited
- Enrollment
- 70
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Diagnosis of idiopathic Parkinson’s Disease (according to modified Hoehn \& Yahr criteria Stages II\-IV) and with suboptimal motor control on L\-DOPA or L\-DOPA combination therapy (i.e. wearing off, peak dose dyskinesias, delayed on or no\-on
- •2\. Subjects receiving a stable regimen of L\-DOPA for at least four weeks prior to screening
- •3\. Patient has gastric half\-time of emptying equal to 70 min as determined by 13C\-oral breath test.
- •4\. Between 40 and 80 years of age, inclusive.
- •5\. Patient has never had a gastrectomy, nor major gastric surgical procedure or any evidence of bowel obstruction or strictures within the previous 12 months
- •6\. Dosage of any concomitant medications has been stable for at least 4 weeks
- •7\. A female subject is eligible to participate if she is of:
- •o Non\-childbearing potential defined as pre\-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<147 pmol/L) is confirmatory].
- •o Child\-bearing potential and is abstinent or agrees to use one of the contraception methods listed in Section 8\.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use
- •contraception until at least 5 days post\-last dose.
Exclusion Criteria
- •1\. Late stage advanced subjects with incapacitating peak dose or biphasic dyskinesia on a stable L\-DOPA regime.
- •2\. Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, neurological (other than Parkinson’s disease), gastro\-intestinal, hematological, endocrinologic, neurological (other than Parkinson’s disease),
- •cardiovascular disease, active malignancy (other than basal cell cancer) or other condition that would in the opinion of the investigator or medical monitor make the subject unsuitable for inclusion in this clinical study.
- •3\. A positive pre\-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- •4\. Patient has a gastric pacemaker
- •5\. Patient is on chronic enteral (e.g., feeding tube) or parenteral feeding
- •6\. Patient has evidence of severe cardiovascular autonomic neuropathy (e.g. history of recurrent syncope in the last 6 months)
- •7\. Estimated (or measured) glomerular filtration rate \= 30 mL/min.
- •8\. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- •9\. Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
Outcomes
Primary Outcomes
Not specified
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