Trials / Completed
CompletedNCT05716126
Single Dose Mass Balance Study With [14C]Iruplinalkib (WX-0593) In Healthy Male Volunteers
Study Evaluating the Mass Balance and Biotransformation of Single Dose [14C]Iruplinalkib (WX-0593) In Healthy Male Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-04-15
- Primary completion
- 2020-12-15
- Completion
- 2021-01-13
- First posted
- 2023-02-08
- Last updated
- 2023-02-08
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05716126. Inclusion in this directory is not an endorsement.