Study of RPT193 in Healthy Adult Male Subjects

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

Phase 1, open-label, absorption, metabolism, excretion, and mass balance study.

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

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