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Study of RPT193 in Healthy Adult Male Subjects

NCT ID: NCT06087978

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2023-10-12

Brief Summary

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

Detailed Description

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

Conditions

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Healthy Male Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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14C RPT193 400 mg

Radiolabelled RPT193

Group Type EXPERIMENTAL

14C RPT193

Intervention Type DRUG

Radiolabelled RPT193

Interventions

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14C RPT193

Radiolabelled RPT193

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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RAPT Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Celerion

Lincoln, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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RPT193-04

Identifier Type: -

Identifier Source: org_study_id