Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With Olanzapine

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 1b Study RDX-002-22-09 has been planned to evaluate the effect of RDX-002 on postprandial triglycerides and ApoB48 levels in normal healthy subjects treated with the atypical antipsychotic drug, olanzapine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Response Pharmaceuticals

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