Clinical trial NCT05857566: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug-induced Weight Gain
Lead sponsor: Response Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-05-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 1b, randomized, open-label, parallel group study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Triglyceride and apolipoprotein B48 (ApoB48)
timeFrame: 7 days
Secondary outcomes:
measure: Triglyceride Level
timeFrame: 7 days
measure: Cmax
timeFrame: 7 days
measure: Fasting Lipids
timeFrame: 7 days
measure: AUC
timeFrame: 7 days
measure: t1/2
timeFrame: 7 days
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Nucleus Network
state: Minnesota
Study officials:
affiliation: Nucleus Network
name: Tricia Stamp, PhD, PA-C
role: PRINCIPAL_INVESTIGATOR
References: