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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06087978
Other study ID # RPT193-04
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 5, 2023
Est. completion date October 12, 2023

Study information

Verified date November 2023
Source RAPT Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
14C RPT193
Radiolabelled RPT193

Locations

Country Name City State
United States Celerion Lincoln Nebraska

Sponsors (1)

Lead Sponsor Collaborator
RAPT Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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