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

NCT ID: NCT05857566

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2023-09-13

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.

Conditions

Drug-induced Weight Gain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RDX-002

50 mg oral tablet; 200 mg BID for 7 days

Group Type: EXPERIMENTAL

RDX-002

Intervention Type: DRUG

A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.

Olanzapine

10 mg oral tablet; 10 mg QD for 14 days

Group Type: OTHER

RDX-002

Intervention Type: DRUG

A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.

Interventions

RDX-002

A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.

Intervention Type: DRUG

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

Exclusion Criteria

• Males and nonpregnant, nonlactating females

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Response Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tricia Stamp, PhD, PA-C

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network

Locations

Nucleus Network

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

RDX-002-22-09

Identifier Type: -

Identifier Source: org_study_id