Status:
COMPLETED
Study of RPT193 in Healthy Adult Male Subjects
Lead Sponsor:
RAPT Therapeutics, Inc.
Conditions:
Healthy Male Subjects
Eligibility:
MALE
19-55 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT06087978
Start Date
July 5 2023
End Date
October 12 2023
Last Update
November 29 2023
Active Locations (1)
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1
Celerion
Lincoln, Nebraska, United States, 68502