Intervention: Olanzapine
Trial phase: Not Applicable
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Olanzapine
Eligibility criteria:
Inclusion Criteria:

Male or female between 18 and 70 years of age
Must have a > or = 6 month history of relevant symptoms of gastroparesis, (e.g., chronic post-prandial fullness, early satiety, postprandial nausea), patients will have a mean of the daily scores over a minimum of 7 days indicating > or = mild (2) and < or = severe (4) post-prandial fullness assessed using the GCSI-DD during the screening period prior to randomization
Documented abnormal gastric emptying within the past 2 years
Has gastroparesis at screening (gastric half-time of emptying > upper limit of normal as determined by wireless motility capsule)
BMI between 18 - 30 kg/m2
A female subject is eligible to participate if she is of non-childbearing potential or child-bearing potential and agrees to use one of the approved contraception methods. Female patients must agree to use contraception for at least 5 days following the last dose of study medication
Subject has never had a gastrectomy, nor major gastric surgical procedure or any evidence of bowel obstruction or strictures within the previous 12 months
Dosage of any concomitant medications has been stable for at least 3 weeks.
Estimated (or measured) glomerular filtration rate ≥ 30 mL/min
QTcB or QTcF < 450 msec or QTc < 480 msec in patients with Bundle Branch. Block based on single or average QTc value of triplicate values obtained over a brief recording period
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
AST and ALT < 2xULN; alkaline phosphatase and bilirubin ≤ 1.5xULN; normal CBC, TSH, and prolactin levels

Exclusion Criteria:

History of diabetes mellitus or hyperglycemia
History of cardiovascular or cerebrovascular disease
History of hyperlipidemia
History of cardiac arrhythmia or long QT syndrome
History of seizure disorder
History of hyperprolactinemia
History of renal dysfunction
History of hepatic impairment
History of schizophrenia, bipolar disorder, or previous use of olanzapine
History of Parkinson's disease, dementia or severe cognitive impairment
History of GI surgery or placement of gastric pacemaker
History of cardiac pacemaker or implantable cardiac defibrillator
History of eating disorder
History of intrapyloric botulinum toxin injections
Subject is on chronic enteral or parenteral feeding
Subject has pronounced dehydration
Subject has evidence of severe cardiovascular autonomic neuropathy (e.g. history of recurrent syncope in the last 6 months)
Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study (e.g., prokinetic drugs, macrolide antibiotics (erythromycin), GLP-1 mimetics)
Regular opiate use
Subjects who are taking drugs that potentially interact with olanzapine including diazepam, lorazepam, alcohol, carbamazepine, fluvoxamine, olanzapine and fluoxetine in combination, CNS acting drugs, levodopa and dopamine agonist, and olanzapine when used in combination with lithium or valproate
History or presence of clinically significant gastro-intestinal, hepatic or renal disease or other condition that would in the opinion of the investigator or medical monitor make the subject unsuitable for inclusion in this clinical study
The subject 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 would make the subject unsuitable for inclusion in this clinical study
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day time-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 females
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Subject is unable to swallow pills