Effect of RDX-002 on Postprandial Triglycerides in Subjects Treated With Olanzapine
Completed · Phase 1
Conditions studied: Drug-induced Weight Gain
In brief
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.
Key facts
- Study ID
- NCT05857566
- Run by
- Response Pharmaceuticals
- People needed
- 24
- Starts
- 2023-05-16
- Expected to finish
- 2023-09-13
- Last updated by the study team
- 2023-11-18
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Nucleus Network — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
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