Study of RPT193 in Healthy Adult Male Subjects

RAPT Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy Male Subjects

Treatments

Drug: 14C RPT193

Study type

Interventional

Funder types

Industry

Identifiers

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