Study of RPT193 in Healthy Adult Male Subjects

Phase 1

Completed

• Conditions: Healthy Male Subjects
• Interventions: Drug: 14C RPT193

• Registration Number: NCT06087978
• Lead Sponsor: RAPT Therapeutics, Inc.

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

Study Timeline

• Study Start: 2023-07-05
• Study First Submitted: 2023-10-04
• Primary Completion: 2023-10-12
• Study Completion: 2023-10-12
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
14C RPT193 400 mg	14C RPT193	Radiolabelled RPT193

Primary Outcome Measures

Name	Time	Method
Characterize pharmacokinetics (PK) profile of RPT193	14 days	Calculation of elimination constant in plasma and urine
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

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States