A Phase 1 interventional study of RDX-002 in Drug-induced Weight Gain, sponsored by Response Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Response Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
405 studies on the registry are indexed under Weight Gain; 52 are open to participants now.
This study's enrollment of 24 is below the median of 83 across 324 interventional studies indexed under Weight Gain.
Browse Weight Gain studies →Response Pharmaceuticals is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 mg oral tablet; 200 mg BID for 7 days
Drug: RDX-002
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.
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
Plan to share: No — No sharing of IPD with other researchers.
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Response Pharmaceuticals