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

Sponsor

Response Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05857566

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Drug-induced Weight Gain	Drug: RDX-002	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Phase 1b, randomized, open-label, parallel group studyPhase 1b, randomized, open-label, parallel group study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open-Label Study of the Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With the Atypical Antipsychotic Drug, Olanzapine

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RDX-002 50 mg oral tablet; 200 mg BID for 7 days	Drug: RDX-002 A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.
Other: Olanzapine 10 mg oral tablet; 10 mg QD for 14 days	Drug: RDX-002 A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.

Arm

Intervention/Treatment

Experimental: RDX-002

50 mg oral tablet; 200 mg BID for 7 days

Drug: RDX-002

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

Other: Olanzapine

10 mg oral tablet; 10 mg QD for 14 days

Drug: RDX-002

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

Outcome Measures

Primary Outcome Measures

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

Triglyceride Level [7 days]
Evaluate the effect of treatment with 10 mg olanzapine on postprandial triglyceride levels and ApoB48 levels in normal healthy volunteers
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Response Pharmaceuticals

Investigators

Principal Investigator: Tricia Stamp, PhD, PA-C, Nucleus Network

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Response Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT05857566

Other Study ID Numbers:

RDX-002-22-09

First Posted:

May 12, 2023

Last Update Posted:

May 12, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Weight Gain

Study Results

No Results Posted as of May 12, 2023