Study of RPT193 in Healthy Adult Male Subjects

Study Overview
=================
Brief Summary
-----------------
Phase 1, open-label, absorption, metabolism, excretion, and mass balance study.

Detailed Description
-----------------
A study of RPT193 in healthy volunteers to evaluate the route(s) of elimination and overall mass balance of RPT193 in urine and feces

Official Title
-----------------
A Phase 1, Open-Label Study to Characterize the Absorption, Metabolism, Excretion (ADME), and Mass Balance of a Single Oral Dose of [14C]-RPT193 in Healthy Adult Male Subjects

Conditions
-----------------
Healthy Male Subjects

Intervention / Treatment
-----------------
* Drug: 14C RPT193


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening Exclusion Criteria: Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit History or presence of clinically significant medical or psychiatric condition or disease History or presence of alcohol or drug abuse within the past 2 years prior to dosing History or presence of: Gastrointestinal ulcers, or history of other significant GI diseases Malignancy within the last 5 years, with the exception of successfully treated basal cell carcinoma. Clinically significant history of angina, myocardial infarction, syncope, clinically significant cardiac arrhythmias, left ventricular hypertrophy, cardiomyopathy, or any other cardiovascular abnormality Ongoing or recent (within 30 days prior to RPT193 administration) bacterial, fungal, or viral infection requiring therapy Known family history of sudden death. Positive for human immunodeficiency virus, hepatitis B, hepatitis C Unwilling to abstain from alcohol, xanthane-containing beverages or food or foods containing grapefruit/Seville orange prior to admission Received radiolabeled substances or exposed to radiation sources over past 12 months

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 14C RPT193 400 mg<br>Radiolabelled RPT193 | Drug: 14C RPT193<br>* Radiolabelled RPT193<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Route(s) of elimination 1 | Amount (in mass equivalents of parent drug) of radioactive drug excreted as TRA in urine and feces | 14 days | 
| Route(s) of elimination 2 | Percent (%) of radioactive drug excreted as TRA in urine and feces | 14 days | 
| Quantitate total radioactivity (TRA) | Percent (%) of each drug-related material (parent and each metabolite) in whole blood, plasma, urine and feces | 14 days | 
| Characterize pharmacokinetics (PK) profile of RPT193 | Calculation of area under the curve (AUC) in plasma and urine | 14 days | 
| Characterize pharmacokinetics (PK) profile of RPT193 | Calculation of peak plasma concentration (Cmax) in plasma and urine | 14 days | 
| Characterize pharmacokinetics (PK) profile of RPT193 | Calculation of time to peak plasma concentration (Tmax) in plasma and urine | 14 days | 
| Characterize pharmacokinetics (PK) profile of RPT193 | Calculation of half-life in plasma and urine | 14 days | 
| Characterize pharmacokinetics (PK) profile of RPT193 | Calculation of elimination constant in plasma and urine | 14 days |