Study of RPT193 in Healthy Adult Male Subjects

Completed · Phase 1

Conditions studied: Healthy Male Subjects

In brief

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

Key facts

Study ID

NCT06087978

Run by

RAPT Therapeutics, Inc.

People needed

7

Starts

2023-07-05

Expected to finish

2023-10-12

Last updated by the study team

2023-11-29

Who can join

Age: 19 and older, up to 55. Sex: male. Healthy volunteers: accepted.

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

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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