Drug-induced Weight Gain
Conditions
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.
Interventions
DRUGRDX-002
A potent, selective, and gut-specific microsomal triglyceride transfer protein (MTP) inhibitor.
Sponsors
Response Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase 1b, randomized, open-label, parallel group study
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triglyceride and apolipoprotein B48 (ApoB48) | 7 days | 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
| Measure | Time frame | Description |
|---|---|---|
| AUC | 7 days | Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine |
| Fasting Lipids | 7 days | Assess the effects of olanzapine and olanzapine with RDX-002 on fasting lipids |
| Triglyceride Level | 7 days | Evaluate the effect of treatment with 10 mg olanzapine on postprandial triglyceride levels and ApoB48 levels in normal healthy volunteers |
| Cmax | 7 days | Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine |
| t1/2 | 7 days | Assess the effect of RDX-002 dosing on the steady-state pharmacokinetics (PK) of olanzapine |
Countries
United States
Outcome results
None listed