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Single Dose Mass Balance Study With [14C]Iruplinalkib (WX-0593) In Healthy Male Volunteers

NCT05716126 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-02-08

No results posted yet for this study

Summary

This is an open-label, single dose, mass balance and biotransformation study conducted at 1 study center in China. This study will evaluate the absorption, distribution, metabolism, and elimination (ADME), mass balance, safety, and tolerability of a single dose of intravenously administered \[14C\]Iruplinalkib (WX-0593) in Chinese healthy male volunteers.

Conditions

  • Healthy

Interventions

DRUG

[14C]Iruplinalkib (WX-0593)

Volunteer will receive a single oral dose of 120 mg \[14C\]Iruplinalkib (WX-0593) as a solution on Day 1

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-15
Primary Completion
2020-12-15
Completion
2021-01-13
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05716126 on ClinicalTrials.gov