Healthy Male Subjects Clinical Trial
Official title:
A Phase I, Open-label, Study of the Absorption, Metabolism and Excretion, of [14C]-Benznidazole (BNZ) Following a Single Oral Dose in Healthy Male Subjects
This Phase I ADME study will be conducted to evaluate the pharmacokinetics of benznidazole.
This will be a single-site, open-label, non-randomized, single oral dose absorption, metabolism and excretion study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to dosing on Day 1. Subjects will be admitted into the Clinical Research Unit (CRU) on Day -1. Subjects will be confined to the CRU until at least Day 11 (240 hours postdose), and will be discharged from the CRU on Day 11 if all the following discharge criteria are met: >90% mass balance recovery; OR plasma/blood radioactivity levels below the limit of quantitation for 2 consecutive collections; and <1% of the total radioactive dose recovered in combined excreta (urine and faeces) in 2 consecutive 24-hour periods. If these criteria are not met by Day 11, subjects will remain in the CRU until all discharge criteria are met up to a maximum of Day 15 to continue 24-hour blood, urine and faeces collections for the analysis of total radioactivity, unless otherwise agreed upon by the Sponsor and Investigator. If the discharge criteria are not met by Day 15, subjects may be asked to collect 24-hour excreta samples on up to 2 further occasions on a nonresidential basis to allow extrapolation of urinary and faecal excretion. If needed, the 2 additional 24-hour nonresidential collections will occur on Day 21 (±1 day) and Day 28 (±1 day). If on the second occasion the subject has still not met the desired criterion, then the subject will be discharged from the study, per Investigator and Sponsor decision. Pharmacokinetic samples and radioanalytical samples will be obtained through at least 240 hours postdose, and possibly up to 4 weeks postdose (radioanalytical samples only), in case of not meeting discharge criteria. Samples for metabolite profiling/identification will be obtained through 240 hours postdose. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05621447 -
A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects
|
Phase 1 | |
| Completed |
NCT02901366 -
Mass Balance Study of FYU-981
|
Phase 2 | |
| Not yet recruiting |
NCT01928563 -
Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine
|
Phase 1 | |
| Completed |
NCT05559554 -
A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Subjects
|
Phase 1 | |
| Completed |
NCT04512872 -
A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT06111196 -
Compare the Pharmacokinetics and Safety of BAT3306 Injection Versus KEYTRUDA® Administered in Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT03317652 -
Effect of Sodium Nitroprusside on Cerebral Blood Flow
|
N/A | |
| Completed |
NCT04655872 -
Mass Balance of Oral [14C]TPN171H in Healthy Male Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT02609711 -
Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects
|
Phase 1 | |
| Withdrawn |
NCT02560363 -
A Study to Compare the Pharmacokinetics of Different Formulations of AZD9977 and the Influence of Food in Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT01261260 -
Effect of Uridine on GABA and High Energy Phosphate Levels in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT05072028 -
Mass Balance and Biotransformation Study of [14C]DBPR108 in Human
|
Phase 1 | |
| Completed |
NCT05446233 -
ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT05275010 -
A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System
|
Phase 1 | |
| Completed |
NCT04839744 -
A Comparative Study of TG103 Produced by Two Manufacturing Processes in Chinese Healthy Male Subjects
|
Phase 1 | |
| Completed |
NCT05792917 -
Bioequivalence Study of Tafolecimab Injections in Chinese Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT03576651 -
A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT04825431 -
Mass Balance Study of [14C] TAS-205 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01819779 -
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60)
|
Phase 1 | |
| Completed |
NCT05126784 -
AVT03 With Prolia in Healthy Male Subjects
|
Phase 1 |