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

Phase 1

Completed

• Conditions: Drug-induced Weight Gain
• Interventions: Drug: RDX-002

• Registration Number: NCT05857566
• Lead Sponsor: Response Pharmaceuticals

Brief 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.

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 Timeline

• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-12
• Study Start: 2023-05-16
• Primary Completion: 2023-07-13
• Study Completion: 2023-09-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RDX-002	RDX-002	50 mg oral tablet; 200 mg BID for 7 days
Olanzapine	RDX-002	10 mg oral tablet; 10 mg QD for 14 days

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nucleus Network; 🇺🇸 Saint Paul, Minnesota, United States