Hepatic Impairment Clinical Trial
Official title:
A Phase 1, Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function
The primary objective is to assess the PK of apraglutide in subjects with hepatic impairment compared with matched control subjects with normal hepatic function following single SC dose administration.
A two stage design, open label, multi-center, non-randomized trial to evaluate the the safety and tolerability of a single subcutaneous dose of 5 mg apraglutide in subjects with varying degrees of hepatic function. The hepatic function will estimated with the Child-Pugh classification. Part 1: 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects with normal hepatic function (Cohort 2). Part 2: 8 subjects with mild hepatic impairment (Cohort 3) and 8 subjects with normal hepatic function (from Cohort 2 where possible and additional subject). Part 2 will be conducted only if the geometric mean ratio (GMR) of AUCinf or AUClast for the moderate hepatic impairment group compared to the control group is ≥2. ;
| 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 |