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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.
Nucleus Network
Saint Paul, Minnesota, United States
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.
Time frame: 7 days
Triglyceride Level
Evaluate the effect of treatment with 10 mg olanzapine on postprandial triglyceride levels and ApoB48 levels in normal healthy volunteers
Time frame: 7 days
Cmax
Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine
Time frame: 7 days
Fasting Lipids
Assess the effects of olanzapine and olanzapine with RDX-002 on fasting lipids
Time frame: 7 days
AUC
Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine
Time frame: 7 days
t1/2
Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine
Time frame: 7 days
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