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
Overview
- Phase
- Phase 1
- Intervention
- 14C RPT193
- Conditions
- Healthy Male Subjects
- Sponsor
- RAPT Therapeutics, Inc.
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Characterize pharmacokinetics (PK) profile of RPT193
- Status
- Completed
- Last Updated
- 2 years ago
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
Investigators
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
Arms & Interventions
14C RPT193 400 mg
Radiolabelled RPT193
Intervention: 14C RPT193
Outcomes
Primary Outcomes
Characterize pharmacokinetics (PK) profile of RPT193
Time Frame: 14 days
Calculation of elimination constant in plasma and urine
Route(s) of elimination 1
Time Frame: 14 days
Amount (in mass equivalents of parent drug) of radioactive drug excreted as TRA in urine and feces
Route(s) of elimination 2
Time Frame: 14 days
Percent (%) of radioactive drug excreted as TRA in urine and feces
Quantitate total radioactivity (TRA)
Time Frame: 14 days
Percent (%) of each drug-related material (parent and each metabolite) in whole blood, plasma, urine and feces