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

Primary Purpose

Drug-induced Weight Gain

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
RDX-002
Sponsored by
Response Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug-induced Weight Gain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    RDX-002

    Olanzapine

    Arm Description

    50 mg oral tablet; 200 mg BID for 7 days

    10 mg oral tablet; 10 mg QD for 14 days

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Triglyceride Level
    Evaluate the effect of treatment with 10 mg olanzapine on postprandial triglyceride levels and ApoB48 levels in normal healthy volunteers
    Cmax
    Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine
    Fasting Lipids
    Assess the effects of olanzapine and olanzapine with RDX-002 on fasting lipids
    AUC
    Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine
    t1/2
    Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine

    Full Information

    First Posted
    April 28, 2023
    Last Updated
    May 11, 2023
    Sponsor
    Response Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05857566
    Brief Title
    Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With Olanzapine
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Response Pharmaceuticals

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Drug-induced Weight Gain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    Phase 1b, randomized, open-label, parallel group study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    RDX-002
    Arm Type
    Experimental
    Arm Description
    50 mg oral tablet; 200 mg BID for 7 days
    Arm Title
    Olanzapine
    Arm Type
    Other
    Arm Description
    10 mg oral tablet; 10 mg QD for 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    RDX-002
    Intervention Description
    A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.
    Primary Outcome Measure Information:
    Title
    Triglyceride and apolipoprotein B48 (ApoB48)
    Description
    Efficacy of treatment with RDX-002 on postprandial triglyceride levels and apolipoprotein B48 (ApoB48) levels in normal healthy volunteers treated with 10 mg olanzapine.
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Triglyceride Level
    Description
    Evaluate the effect of treatment with 10 mg olanzapine on postprandial triglyceride levels and ApoB48 levels in normal healthy volunteers
    Time Frame
    7 days
    Title
    Cmax
    Description
    Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine
    Time Frame
    7 days
    Title
    Fasting Lipids
    Description
    Assess the effects of olanzapine and olanzapine with RDX-002 on fasting lipids
    Time Frame
    7 days
    Title
    AUC
    Description
    Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine
    Time Frame
    7 days
    Title
    t1/2
    Description
    Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    William J Sasiela, PhD
    Phone
    609-651-3773
    Email
    bill@reduxtherapeutics.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tricia Stamp, PhD, PA-C
    Organizational Affiliation
    Nucleus Network
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No sharing of IPD with other researchers.

    Learn more about this trial

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

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