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

Response Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Drug-induced Weight Gain

Treatments: Drug: RDX-002

Study type: Interventional

Funder types: Industry

Identifiers

NCT05857566

RDX-002-22-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

RDX-002

Experimental group

Description:

50 mg oral tablet; 200 mg BID for 7 days

Treatment:

Drug: RDX-002

Olanzapine

Other group

Description:

10 mg oral tablet; 10 mg QD for 14 days

Treatment:

Drug: RDX-002