Study of RPT193 in Healthy Adult Male Subjects

NCT06087978 | Completed Phase 1 FDA Drug

• 1 other identifier: RPT193-04
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

14C RPT193 400 mg

EXPERIMENTAL

Radiolabelled RPT193

Drug: 14C RPT193

Interventions

14C RPT193 DRUG

Radiolabelled RPT193

14C RPT193 400 mg

Eligibility Criteria

• Age: 19 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RAPT Therapeutics, Inc.: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 18, 2023
• Study Start: July 5, 2023
• Primary Completion: October 12, 2023
• Study Completion: October 12, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

US (1)