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

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

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.

Study Overview

• Status: Completed
• Conditions: Drug-induced Weight Gain
• Intervention / Treatment: Drug: RDX-002

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Response Pharmaceuticals
• Investigators: Principal Investigator: Tricia Stamp, PhD, PA-C, Nucleus Network

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Actual): July 13, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: RDX-002-22-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing of IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No