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

NCT05857566 | Completed Phase 1 FDA Drug

• 1 other identifier: RDX-002-22-09
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-induced Weight Gain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Triglyceride Level

  7 days

• Cmax

  7 days

• Fasting Lipids

  7 days

• AUC

  7 days

• t1/2

  7 days

Study Arms (2)

RDX-002

EXPERIMENTAL

50 mg oral tablet; 200 mg BID for 7 days

Drug: RDX-002

Olanzapine

OTHER

10 mg oral tablet; 10 mg QD for 14 days

Drug: RDX-002

Interventions

RDX-002 DRUG

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

Olanzapine; RDX-002

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Response Pharmaceuticals: lead

Study Sites (1)

Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

Study Officials

• Tricia Stamp, PhD, PA-C

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1b, randomized, open-label, parallel group study

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 12, 2023
• Study Start: May 16, 2023
• Primary Completion: July 13, 2023
• Study Completion: September 13, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)