Status:
COMPLETED
The Effect of Single Doses of the Motilin Receptor Agonist GSK962040 in Type I Diabetic Patients With Gastroparesis
Lead Sponsor:
GlaxoSmithKline
Conditions:
Gastroparesis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the pharmacodynamic effects (gastric emptying), safety, tolerability, and pharmacokinetics of single doses of GSK962040 in Type 1 diabetic patients with gastropa...
Eligibility Criteria
Inclusion
- Controlled Type 1 Diabetes Mellitus (glucose \< 250 mg/dL) with onset \< 30 years of age.
- Male or female between 18 and 70 years of age, inclusive.
- Patient has documented diagnosis of moderate to severe gastroparesis (\> 30% at 2 h as determined by scintigraphy; or t1/2b \> 109 min as determined by 13C-octanoic acid breath test). All of the following apply:
- Confirmed delayed gastric emptying (properly conducted gastric emptying assessments within last 6 months acceptable) AND a minimum 3 month history of relevant symptoms for gastroparesis (e.g., chronic postprandial fullness, postprandial nausea, vomiting)
- A female patient is eligible to participate if she is of:
- Non-childbearing potential
- Child-bearing potential and agrees to use contraception for at least 4 days following the last dose of study medication.
- Male patients must agree to use contraception from the time of the first dose of study medication through at least 4 days after the last dose of study medication.
- Body weight ≤110 kg and BMI \< 32.0 kg/m2 (inclusive).
- Patient has never had a gastrectomy, nor major gastric surgical procedure or any evidence of bowel obstruction within the previous 12 months
- Dosage of any concomitant medications has been stable for at least 3 weeks, except for routine adjustments in daily insulin treatments
- HbA1c level is ≤ 10.0%
- Calculated creatinine clearance \> or equal to 50 ml/min
- QTcB or QTcF \< 450 msec or QTc\<480msec in patients with Bundle Branch Block based on single or average QTc value of triplicate values obtained over a brief recording period.
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion
- Patient has acute severe gastroenteritis
- Patient has a gastric pacemaker
- Patient is on chronic parenteral feeding
- Patient has daily persistent severe vomiting
- Patient has pronounced dehydration
- Patient has had clinical diabetic ketoacidosis in last 4 weeks
- Patient has a history of eating disorders (anorexia nervosa, binge eating, bulimia)
- Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study (e.g., prokinetic drugs, macrolide antibiotics (erythromycin))
- Patient is taking opiates.
- Use of prohibited medications listed in Section 9.2 within the restricted timeframe relative to the first dose of study medication.
- History or presence of clinically significant gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Presence of thyroid dysfunction (NOTE: patients with abnormal TSH at screening/baseline are not eligible. Patients with a history of hypothyroidism on a stable dose of thyroid replacement therapy are eligible to participate in the study).
- The patient has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum or urine hCG test (from the first urine of the day) at screening or prior to dosing.
- Lactating or pregnant females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Patients deemed unable to comply with the procedures outlined in the protocol may be excluded at the Investigator's discretion.
- For male volunteers: An unwillingness of the male patient to comply with the contraception requirements listed in Section 8.1, from the time of the first dose of study medication until at least 4 days following administration of the last dose of study medication.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00861809
Start Date
June 1 2009
End Date
November 1 2010
Last Update
January 30 2017
Active Locations (2)
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1
GSK Investigational Site
Leuven, Belgium, 3000
2
GSK Investigational Site
Stockholm, Sweden, SE-171 76