Clinical Trials Logo
  1. Home
  2. Advanced Breast Cancer
  3. NCT06290466

Clinical Study on Pharmacokinetics of FCN-437c Capsule and Its Effect on QT Interval in Healthy Subjects

Advanced Breast Cancer Clinical Trial

Official title:
A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Design to Evaluate the Pharmacokinetics and Effects on QT Interval of a Single Oral Dose of FCN-437c Capsule in Healthy Subjects.

Clinical Trial Summary

This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial in healthy subjects.In healthy subjects, 300mg and 400mg FCN-437c capsules were taken orally for a single time. C-QTc effect model was used to evaluate the influence of blood concentration on QT interval, and the pharmacokinetic characteristics and safety of FCN-437c were also evaluated.Based on the C-QTc effect model, this study quantitatively analyzed the relationship between ΔΔQTcF and blood concentration, and evaluated the upper limit of 90% bilateral confidence interval of ΔΔQTcF corresponding to the geometric mean of Cmax at clinically relevant dose of FCN-437c capsule. This study plans to set up 2 dose groups, low-dose group 300mg and high-dose group 400mg.Nine healthy subjects were planned to be enrolled in each dose group, with a 2:1 ratio of placebo control. This study was carried out in the order of dose from low to high. After the administration of the low-dose group (300mg) and the safety assessment on the fourth day after administration, the study of the high-dose group (400mg) was decided through comprehensive evaluation.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06290466
Study type Interventional
Source Ahon Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date November 11, 2022
Completion date February 8, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04653740 - Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer N/A
Completed NCT02091960 - A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer Phase 2
Recruiting NCT05156619 - Health Care Disparities in Culturally Diverse, Special Needs & Disadvantaged Populations - Bridging the Gap
Recruiting NCT05173103 - Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
Withdrawn NCT05191004 - Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC Phase 1/Phase 2
Completed NCT00754325 - Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor Phase 2
Recruiting NCT04953377 - PFMT Educational Intervention for Patients With Advancer Breast Cancer N/A
Completed NCT03240224 - Bioinformation Therapy for Breast Cancer Phase 2/Phase 3
Recruiting NCT06193525 - FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test Phase 2
Completed NCT03312738 - A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor Phase 2
Active, not recruiting NCT05063786 - Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) Phase 3
Recruiting NCT05655598 - TAS-116 Plus Palbociclib in Breast and Rb-null Cancer Phase 1
Active, not recruiting NCT02499146 - Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer Phase 1
Completed NCT00445458 - A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer Phase 1/Phase 2
Recruiting NCT04456855 - Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
Completed NCT04408118 - First Line Atezolizumab, Paclitaxel, and Bevacizumab (Avastin®) in mTNBC Phase 2
Recruiting NCT04222413 - Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors Phase 1
Completed NCT03205761 - Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer Phase 2
Withdrawn NCT04316169 - Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer Phase 1
Completed NCT00546104 - Phase II Dasatinib Study in Advanced Breast Cancer Phase 2