Healthy Male Subjects
Conditions
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
Interventions
DRUG14C RPT193
Radiolabelled RPT193
Sponsors
RAPT Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Route(s) of elimination 1 | 14 days | Amount (in mass equivalents of parent drug) of radioactive drug excreted as TRA in urine and feces |
| Route(s) of elimination 2 | 14 days | Percent (%) of radioactive drug excreted as TRA in urine and feces |
| Quantitate total radioactivity (TRA) | 14 days | Percent (%) of each drug-related material (parent and each metabolite) in whole blood, plasma, urine and feces |
| Characterize pharmacokinetics (PK) profile of RPT193 | 14 days | Calculation of area under the curve (AUC) in plasma and urine |
Countries
United States
Outcome results
None listed