Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With Olanzapine
Drug-induced Weight Gain
About this trial
This is an interventional treatment trial for Drug-induced Weight Gain
Eligibility Criteria
Inclusion Criteria: A glycated hemoglobin (HbA1c) level of <5.7% at Screening A 12-lead electrocardiogram (ECG) at Screening which, in the opinion of the Investigator, had no abnormalities that compromised safety in this study Hematology, clinical chemistry and urinalysis at Screening, the results of which fall within normal parameter ranges and/or are deemed clinically acceptable by the Investigator Exclusion Criteria Males and nonpregnant, nonlactating females Exclusion Criteria: Any prior use of or contraindication to atypical antipsychotics Concomitant use of drugs known to impact the PK of olanzapine Type 1 or Type 2 diabetes Recent CV event Uncontrolled hypertension Fasting triglycerides ≥400 mg/dL Fasting glucose ≥100 mg/dL Any condition that impacts the absorption of dietary fats Significant gastrointestinal disorders Gall bladder disease Uncontrolled hypothyroidism Liver disease or dysfunction Renal disease or dysfunction Gastrointestinal conditions Hematologic disorders Active malignancy Psychiatric disorder History of drug or alcohol abuse Pregnant, breastfeeding, or intending to become pregnant Use of weight loss products Blood donation or loss within 30 days prior to Screening
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Other
RDX-002
Olanzapine
50 mg oral tablet; 200 mg BID for 7 days
10 mg oral tablet; 10 mg QD for 14 days