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OpenTrials
Completed

NCT Number: NCT06087978

Study of RPT193 in Healthy Adult Male Subjects

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

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Key information

Conditions

Healthy Male Subjects

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

About this study

A study of RPT193 in healthy volunteers to evaluate the route(s) of elimination and overall mass balance of RPT193 in urine and feces

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

14C RPT193

Drug

Radiolabelled RPT193

Primary outcomes

  1. Route(s) of elimination 1

    Time frame: 14 days

    Amount (in mass equivalents of parent drug) of radioactive drug excreted as TRA in urine and feces

  2. Route(s) of elimination 2

    Time frame: 14 days

    Percent (%) of radioactive drug excreted as TRA in urine and feces

  3. Quantitate total radioactivity (TRA)

    Time frame: 14 days

    Percent (%) of each drug-related material (parent and each metabolite) in whole blood, plasma, urine and feces

  4. Characterize pharmacokinetics (PK) profile of RPT193

    Time frame: 14 days

    Calculation of area under the curve (AUC) in plasma and urine

  5. Characterize pharmacokinetics (PK) profile of RPT193

    Time frame: 14 days

    Calculation of peak plasma concentration (Cmax) in plasma and urine

  6. Characterize pharmacokinetics (PK) profile of RPT193

    Time frame: 14 days

    Calculation of time to peak plasma concentration (Tmax) in plasma and urine

  7. Characterize pharmacokinetics (PK) profile of RPT193

    Time frame: 14 days

    Calculation of half-life in plasma and urine

  8. Characterize pharmacokinetics (PK) profile of RPT193

    Time frame: 14 days

    Calculation of elimination constant in plasma and urine

Sponsors and collaborators

Lead sponsor

RAPT Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2023
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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