DZD9008 PK Study in Hepatic Impairment Subjects

NCT06084104 | Completed Phase 1 FDA Drug

• 1 other identifier: DZ2022E0007
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma (peak) drug concentration [Cmax]

  Day 1 to day 14

• Area under plasma concentration time curve from zero to infinity (AUCinf)

  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 Outcomes (15)

• Apparent total body clearance (CL/F)

  Day 1 to day 14

• Area under plasma concentration time curve from zero to infinity (AUCinf)

  Day 1 to day 14

• Terminal phase half-life (t1/2),

  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

Study Arms (2)

Hepatic impairment

EXPERIMENTAL

Subjects with hepatic impairment

Drug: DZD9008

Healthy Subject

EXPERIMENTAL

Subjects with normal hepatic function

Drug: DZD9008

Interventions

DZD9008 DRUG

A single oral dose of 200mg DZD9008

Hepatic impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is male or female 18 to 75 years of age, inclusive, at screening.
• The subject has a BMI of 18.0 to 40.0 kg/m2, inclusive, at screening and check-in.
• The subject has a minimum body weight of 50.0 kg, at screening and check-in.
• The subject has a resting pulse rate of ≥ 40 and \< 100 beats per minute with no clinically significant deviation as judged by the investigator.
• The subject agrees to comply with all protocol requirements.
• The subject is able to provide written informed consent.
• The subject has normal hepatic function. No known or suspected hepatic impairment based on liver function tests (e.g., ALT, AST, ALP, and bilirubin), albumin, and prothrombin time is defined as the following with a single repeat permitted to assess eligibility if needed, at screening and check-in:
• ALT and AST ≤ ULN
• Total bilirubin ≤ ULN (subjects with a history of Gilbert syndrome are eligible if they only have elevated total bilirubin)
• ALP ≤ ULN
• Albumin ≥ 3.6 g/dL
• Prothrombin time ≤ ULN
• The subject has a resting blood pressure of 90 to 145 mmHg (systolic) and 40 to 95 mmHg (diastolic), at screening and check-in.
• The subject has a QTcF of ≤ 450 msec, at screening and check-in.
• The subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead ECG results, and physical examination findings.

You may not qualify if:

• The subject has a history or clinical manifestations of a significant neurological, renal, cardiovascular, gastrointestinal, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
• The subject has any surgical or medical condition that may alter the absorption, distribution, metabolism, or excretion of drugs (e.g., gastrectomy).
• The subject has a history of cancer (malignancy) with the following exceptions:
• adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix, or
• other malignancies which have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study
• The subject has a history of being immunocompromised or has a positive test result for HIV types 1 or 2 antibodies at screening.
• The subject has an acute or chronic infection requiring treatment with oral antibiotics (except, rifaximin for the treatment of hepatic encephalopathy), antivirals, antiparasitic, antiprotozoals, or antifungals within 4 weeks prior to Day 1 or superficial skin infection within 1 week prior to Day 1.
• The subject has a history of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of long QT syndrome), has clinically significant hypokalemia or hypomagnesemia, and is taking concomitant medications that prolong the QT/QTc interval.
• The subject has uncontrolled hypertension despite optimal medical management.
• The subject had arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study drug administration.
• The subject tests positive for breath alcohol test at screening and on check-in (Day 1).
• The subject is unable or unwilling to restrict smoking to 5 cigarettes or less per day.
• The subject is involved in strenuous activity or contact sports within 24 hours of the first dose of study drug or during the study.
• The subject has donated blood (excluding plasma donation) of ≥ 500 mL within 60 days before the first dose of study drug.
• The subject has poor peripheral venous access.

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead
• PPD Development, L.P.: collaborator

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

American Research Corporation

San Antonio, Texas, 78215, United States

Location

Study Officials

• Thomas C Marbury, MD

  Orlando Clinical Research Center

  PRINCIPAL INVESTIGATOR

• Eric Lawitz, MD

  Texas Liver Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: October 16, 2023
• Study Start: October 17, 2023
• Primary Completion: June 12, 2024
• Study Completion: October 23, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

US (2)