Study of RPT193 in Healthy Adult Male Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: 14C RPT193

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 14C RPT193 400 mg; Radiolabelled RPT193	Drug: 14C RPT193; Radiolabelled RPT193

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Route(s) of elimination 1	Amount (in mass equivalents of parent drug) of radioactive drug excreted as TRA in urine and feces	14 days
Route(s) of elimination 2	Percent (%) of radioactive drug excreted as TRA in urine and feces	14 days
Quantitate total radioactivity (TRA)	Percent (%) of each drug-related material (parent and each metabolite) in whole blood, plasma, urine and feces	14 days
Characterize pharmacokinetics (PK) profile of RPT193	Calculation of area under the curve (AUC) in plasma and urine	14 days
Characterize pharmacokinetics (PK) profile of RPT193	Calculation of peak plasma concentration (Cmax) in plasma and urine	14 days
Characterize pharmacokinetics (PK) profile of RPT193	Calculation of time to peak plasma concentration (Tmax) in plasma and urine	14 days
Characterize pharmacokinetics (PK) profile of RPT193	Calculation of half-life in plasma and urine	14 days
Characterize pharmacokinetics (PK) profile of RPT193	Calculation of elimination constant in plasma and urine	14 days

Collaborators and Investigators

• Sponsor: RAPT Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Actual): October 12, 2023
• Study Completion (Actual): October 12, 2023

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RPT193-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No