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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. It is a randomized, open-label, parallel group study that will be conducted at a single study site in the US. Normal, healthy subjects aged 18-50 years and with a body mass index (BMI) of 18-27.5 kg/m2 will be eligible for screening. Screening (Day -28) will begin approximately 28 days prior to Baseline (Day 1). Subjects will be admitted to the clinical research unit (CRU) on the morning of Day -1 and will remain in the CRU until discharge on Day 16.

Official Title
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A Randomized, Open-Label Study of the Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With the Atypical Antipsychotic Drug, Olanzapine

Conditions
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Drug-induced Weight Gain

Intervention / Treatment
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* Drug: RDX-002


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase 1b, randomized, open-label, parallel group study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RDX-002<br>50 mg oral tablet; 200 mg BID for 7 days | Drug: RDX-002<br>* A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.<br>|
| Other: Olanzapine<br>10 mg oral tablet; 10 mg QD for 14 days | Drug: RDX-002<br>* A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride and apolipoprotein B48 (ApoB48) | Efficacy of treatment with RDX-002 on postprandial triglyceride levels and apolipoprotein B48 (ApoB48) levels in normal healthy volunteers treated with 10 mg olanzapine. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride Level | Evaluate the effect of treatment with 10 mg olanzapine on postprandial triglyceride levels and ApoB48 levels in normal healthy volunteers | 7 days | 
| Cmax | Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine | 7 days | 
| Fasting Lipids | Assess the effects of olanzapine and olanzapine with RDX-002 on fasting lipids | 7 days | 
| AUC | Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine | 7 days | 
| t1/2 | Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine | 7 days |