NCT05857566

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Response Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	RDX-002	A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.

Timeline

• Start date: 2023-05-16
• Primary completion: 2023-07-13
• Completion: 2023-09-13
• First posted: 2023-05-12
• Last updated: 2023-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study