Study of RPT193 in Healthy Adult Male Subjects

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06087978
• Other study ID #: RPT193-04
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Healthy Male Subjects

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