Healthy Male Subjects Clinical Trial
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
Verified date | November 2023 |
Source | RAPT Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Phase 1, open-label, absorption, metabolism, excretion, and mass balance study.
Status | Completed |
Enrollment | 7 |
Est. completion date | October 12, 2023 |
Est. primary completion date | October 12, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 19 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Celerion | Lincoln | Nebraska |
Lead Sponsor | Collaborator |
---|---|
RAPT Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Route(s) of elimination 1 | Amount (in mass equivalents of parent drug) of radioactive drug excreted as TRA in urine and feces | 14 days | |
Primary | Route(s) of elimination 2 | Percent (%) of radioactive drug excreted as TRA in urine and feces | 14 days | |
Primary | Quantitate total radioactivity (TRA) | Percent (%) of each drug-related material (parent and each metabolite) in whole blood, plasma, urine and feces | 14 days | |
Primary | Characterize pharmacokinetics (PK) profile of RPT193 | Calculation of area under the curve (AUC) in plasma and urine | 14 days | |
Primary | Characterize pharmacokinetics (PK) profile of RPT193 | Calculation of peak plasma concentration (Cmax) in plasma and urine | 14 days | |
Primary | Characterize pharmacokinetics (PK) profile of RPT193 | Calculation of time to peak plasma concentration (Tmax) in plasma and urine | 14 days | |
Primary | Characterize pharmacokinetics (PK) profile of RPT193 | Calculation of half-life in plasma and urine | 14 days | |
Primary | Characterize pharmacokinetics (PK) profile of RPT193 | Calculation of elimination constant in plasma and urine | 14 days |
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