Hepatic Impairment Clinical Trial
Official title:
A Single Dose Evaluation of the Effects of Moderate (Child-Pugh Grade B) Hepatic Impairment on Deflazacort Pharmacokinetics
This is a non-randomized, open-label, single-dose study to compare the PK of 21-desacetyl-DFZ and, if data permits, deflazacort in 8 subjects with moderate hepatic impairment (based on the Child Pugh classification, Grade B) to that of 8 healthy matched control subjects (age, body mass index [BMI], and gender).
This is a non-randomized, open-label, single-dose study to compare the PK of 21-desacetyl-DFZ
and, if data permits, deflazacort in 8 subjects with moderate hepatic impairment (based on
the Child Pugh classification, Grade B) to that of 8 healthy matched control subjects (age,
body mass index [BMI], and gender).
On Day 1, a single oral dose of deflazacort will be administered followed by serial blood
sampling for 24 hours to assess the PK of 21-desacetyl-DFZ and, if data permits, deflazacort.
Safety will be monitored throughout the study by repeated clinical and laboratory
evaluations.
Subjects will return to the Clinical Research Unit (CRU) 3 days (± 1 day) following study
drug administration to determine if any adverse events (AEs) have occurred since the last
study visit. Subjects who terminate the study early will be contacted if the Principal
Investigator (PI) deems necessary.
A total of sixteen (16) adult male and female subjects will be enrolled. Hepatic Impaired
Cohort: Eight (8) subjects with moderate hepatic insufficiency (a score of 7 to 9, on the
Child-Pugh scale).
Healthy Match Control Cohort: Eight (8) healthy subjects. Subjects will be matched for age [±
15 years], BMI [± 15 %], and gender [1:1] to the subjects in the moderate hepatic impaired
cohort.
;
| 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 |
NCT02244827 -
Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment
|
Phase 1 | |
| Completed |
NCT02245243 -
Pharmacokinetics of Delafloxacin in Subjects With and Without 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 |