DZD9008 PK Study in Hepatic Impairment Subjects
- Registration Number
- NCT06084104
- Lead Sponsor
- Dizal Pharmaceuticals
- Brief Summary
This study will investigate the pharmacokinetics, safety, and tolerability of DZD9008 in subjects with hepatic impairment compared to subjects with normal hepatic function
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hepatic impairment DZD9008 Subjects with hepatic impairment Healthy Subject DZD9008 Subjects with normal hepatic function
- Primary Outcome Measures
Name Time Method Area under plasma concentration time curve from zero to infinity (AUCinf) Day 1 to day 14 Maximum observed plasma (peak) drug concentration [Cmax] Day 1 to day 14 Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast) Day 1 to day 14
- Secondary Outcome Measures
Name Time Method Vital sign measurements: systolic and diastolic blood pressure, pulse rate, respiratory rate and body temperature Day 1 to day 14 Terminal phase half-life (t1/2), Day 1 to day 14 Adverse events Day 1 to day 14 Apparent total body clearance (CL/F) Day 1 to day 14 Unbound area under plasma concentration time curve from zero to infinity (AUC0-inf, u) Day 1 to day 14 Unbound maximum observed plasma (peak) drug concentration (Cmax, u) Day 1 to day 14 Unbound apparent total body clearance (CLu/F) Day 1 to day 14 Unbound apparent volume of distribution (Vz,u/F) Day 1 to day 14 Clinical laboratory test results: hematology, coagulation, serum chemistry, urinalysis Day 1 to day 14 Unbound area under the plasma concentration-curve from time zero to last quantifiable concentration (AUC0-last, u) Day 1 to day 14 Area under plasma concentration time curve from zero to infinity (AUCinf) Day 1 to day 14 Time to maximum observed plasma concentration (Tmax) Day 1 to day 14 Fraction unbound (Fu) Day 1 to day 14 12-lead ECG results: tracings, rhythm, RR interval, PR interval, QRS width, QT interval, and QTcF Day 1 to day 14 Physical examination findings: assessment of skin, head, ears, eyes, nose, throat, neck, thyroid, lungs, heart, cardiovascular, abdomen, lymph nodes, and musculoskeletal system/extremities Day 1 to day 14
Trial Locations
- Locations (2)
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
American Research Corporation
🇺🇸San Antonio, Texas, United States