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NCT05836805
A Phase 1,Single-center,Open-label Study Investigating the Mass Balance,Pharmacokinetics and Metabolism of [14C]XZP-3621 in Healthy Male Subjects
Phase 1 trial testing [14C]XZP-3621 in Healthy Volunteers in 6 participants. Status unknown.
1 August 2023
Quick facts
| Lead sponsor | Xuanzhu Biopharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 1 May 2023 |
| Primary completion | 1 August 2023 |
| Estimated completion | 1 September 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- [14C]XZP-3621 — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Xuanzhu Biopharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 45, male only, with Healthy Volunteers. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Total recovery of radioactivity in urine and feces
Time frame: Assessments will be made up to 19 days post dose
Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample. -
Radioactivity concentration of each plasma sample
Time frame: Assessments will be made up to 19 days post dose
Use liquid scintillation counter to evaluate Radioactivity concentration of each plasma(DPM/ml) sample -
Metabolic profiling for XZP-3621 will be determined in plasma, urine and fecal samples
Time frame: Assessments will be made up to 19 days post dose
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces. -
Maximum exposure in plasma will be determined for XZP-3621, XZP-5089 metabolite and total radioactivity
Time frame: Assessments will be made up to 19 days post dose
Cmax (maximum observed plasma concentration) will be reported directly from each analyte's data -
The overall exposure in plasma will be determined for XZP-3621, metabolite and total radioactivity
Time frame: Assessments will be made up to 19 days post dose
AUC0-∞ (Area under the plasma concentration time profile from time 0 extrapolated to infinite time) will be determined, using Linear/Log trapezoidal method, from plasma concentration data for each analyte -
The terminal elimination half life in plasma will be estimated from plasma profiles over time for XZP-3621, metabolite and total radioactivity
Time frame: Assessments will be made up to 19 days post dose
t1/2 (apparent terminal elimination half life) will be estimated for each analyte from the terminal portion of its plasma concentration versus time plot
Sponsor's own description
This non-randomized, single group, open-label study will investigate the mass balance, routes of elimination, pharmacokinetics, metabolism, safety and tolerability of a single oral dose of \[14C\]XZP-3621 in healthy volunteers.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05836805
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Xuanzhu Biopharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07345689 — A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations · Phase 4 · not yet recruiting
- NCT07330531 — Drug-drug Interaction Study of Rifampin and Anaprazole Sodium · Phase 4 · not yet recruiting
- NCT05586568 — Drug-drug Interaction Study of XZP-3621 Tablet · Phase 1 · unknown
- NCT05478109 — A Clinical Trial of XZP-3287 for Material Balance · Phase 1 · unknown
- NCT05257395 — A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer · Phase 3 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05836805 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xuanzhu Biopharmaceutical Co., Ltd.
- Last refreshed: 19 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05836805.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing