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Study of RPT193 in Healthy Adult Male Subjects

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RAPT Therapeutics

Status and phase

Completed
Phase 1

Conditions

Healthy Male Subjects

Treatments

Drug: 14C RPT193

Study type

Interventional

Funder types

Industry

Identifiers

NCT06087978
RPT193-04

Details and patient eligibility

About

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

Full 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

Enrollment

7 patients

Sex

Male

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

7 participants in 1 patient group

14C RPT193 400 mg
Experimental group
Description:
Radiolabelled RPT193
Treatment:
Drug: 14C RPT193

Trial contacts and locations

1

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Central trial contact

Vice President, Clinical Development

Data sourced from clinicaltrials.gov

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