Hepatic Impairment Clinical Trial
Official title:
A Phase I, Single-Dose, Non-Randomised, Open-Label, Parallel-Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of balcinrenone in patients with mild and moderate hepatic impairment in comparison to a matched healthy control group.
This is an open-label, non-randomised, multicentre, parallel-group, single-dose study to examine the PK, safety, and tolerability of balcinrenone 50 mg administered orally to male and female participants with mild or moderate hepatic impairment compared with control participants with normal hepatic function. Eight participants with mild impairment and 8 participants with moderate impairment per CP classification and 8 to 12 participants with normal hepatic function matched on a group level regarding age, BMI, and sex to the impaired groups are planned for study intervention. All participants will receive a single dose of balcinrenone 50 mg on Day 1 following an overnight fast. Study intervention will be administered orally with approximately 240 mL of water. Child-Pugh scoring will be used to determine the level of hepatic impairment. Participants will be enrolled into the following groups based on their CP classification score as determined at screening: - Group 1: Participants with mild hepatic impairment (CP Class A, score of 5 or 6). - Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). - Group 3: Participants with normal hepatic function matched on a group level regarding age, BMI, and sex to the impaired groups. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05009680 -
A Single and Repeat Dose Trial in Participants With Hepatic Impairment
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
| Terminated |
NCT05517226 -
Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment
|
Phase 1 | |
| Completed |
NCT03983161 -
A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment
|
Phase 1 | |
| Completed |
NCT04546789 -
Effect of Hepatic Impairment on M2951 (BTK Inhibitor) PK
|
Phase 1 | |
| Completed |
NCT03282513 -
A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function
|
Phase 1 | |
| Recruiting |
NCT05976321 -
A Study of TAK-279 in Adults With or Without Liver Damage
|
Phase 1 | |
| Completed |
NCT04473664 -
A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment
|
Phase 1 | |
| Recruiting |
NCT05484206 -
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
|
Phase 1 | |
| Completed |
NCT03290443 -
A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.
|
Phase 1 | |
| Completed |
NCT02245243 -
Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment
|
Phase 1 | |
| Completed |
NCT02244827 -
Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment
|
Phase 1 | |
| Completed |
NCT02004587 -
Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers
|
Phase 1 | |
| Completed |
NCT01621633 -
A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
|
Phase 2 | |
| Completed |
NCT01493869 -
Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
|
Phase 1 | |
| Completed |
NCT04482270 -
A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function
|
Phase 1 | |
| Completed |
NCT02115347 -
Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)
|
Phase 1 | |
| Recruiting |
NCT04950764 -
An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
|
Phase 1 | |
| Completed |
NCT06161259 -
Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment
|
Phase 1 | |
| Completed |
NCT05481411 -
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment
|
Phase 1 |