Pharmacokinetic and Mass Balance Study of Oral-Administrated [14C]-DZD9008 in Healthy Male Subjects

NCT05159895 | Completed Phase 1 FDA Drug

• 1 other identifier: DZ2021E0003
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1, open-label, ADME study with single oral administration of \[14C\]-DZD9008 in healthy subjects.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• Percentage of Total Radioactivity (Cum% Dose) Recovered in Urine Relative to the Administered Radioactive Dose

  Up to 85 days

• Percentage of Total Radioactivity (Cum% Dose) Recovered in Feces Relative to the Administered Radioactive Dose

  Up to 85 days

• Amount of Total Radioactivity Excreted in Urine (Ae [UR])

  Up to 85 days

• Amount of Total Radioactivity Excreted in Feces (Ae [Fe])

  Up to 85 days

• Percentage of Administered Radioactive Dose (%Dose) Excreted in Urine for [14C]-DZD9008

  Up to 85 days

• Percentage of Administered Radioactive Dose (%Dose) Excreted in Feces for [14C]-DZD9008

  Up to 85 days

Study Arms (1)

[14C]-DZD9008

EXPERIMENTAL

A Single dose of \[14C\]-DZD9008

Drug: [14C]-DZD9008

Interventions

[14C]-DZD9008 DRUG

Each subject will receive a total of 100 mg DZD9008 oral suspension containing approximately 1 μCi of \[14C\] as a single administration

[14C]-DZD9008

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects between 18 and 60 years of age, with body mass index of 18.0 to 30.0 kg/m2. Body weight: ≥55 kg,and ≤ 100 kg.
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, clinical laboratory evaluations.
• Regular bowel movements (ie, average production of ≥ 1 or ≤ 3 bowel movements a day).
• Adhere to specific contraception requirements
• Creatinine clearance ≥ 90 mL/min/1.73 m2.
• Aspartate aminotransferase and alanine aminotransferase must be ≤2.5 × upper limit of normal (ULN) and total bilirubin ≤1.5 × ULN.

You may not qualify if:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, respiratory, endocrine, or psychiatric disorder.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator, or history of hypersensitivity to DZD9008, its excipients, or drugs with a similar chemical structure or class.
• History of stomach or intestinal surgery history or presence of hepatic or renal disease or surgical procedure that would potentially alter absorption and/or excretion of orally-administered drugs (uncomplicated appendectomy and hernia repair will be allowed; cholecystectomy will not be allowed).
• Any clinically significant abnormalities in physical examination performed at check-in, vital signs (supine systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg, and pulse rate ≥100 or ≤35 beats per minute) or clinical laboratory evaluations as judged by the investigator (or designee).
• Any clinically important abnormalities in rhythm, conduction, or morphology of resting 12-lead ECG, QTcF interval \>450 msec, as judged by the investigator (or designee).
• A history of additional risk factors for Torsades de pointes (eg, heart failure, hypokalemia, family history of Long QT syndrome).
• Positive/reactive results on screening tests for serum hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (Appendix 2).
• Acute illness, surgical procedures or trauma from within 2 weeks before screening until the first administration of the IMP.
• Subjects with active malignancy or neoplastic disease in the previous 12 months.
• Ongoing or planned inpatient surgery, dental procedure, or hospitalization during the study.
• Administration of a coronavirus disease 2019 (COVID-19) vaccine in the past 30 days prior to dosing.
• Use or intend to use any medications/products known to alter drug AME processes, including St. John's wort, within 30 days prior to check-in, unless deemed acceptable by the investigator (or designee).
• Use or intend to use any prescription medications/products within 28 days prior to check-in, unless deemed acceptable by the investigator (or designee). Exceptions may be allowed on a case by case basis as agreed by the investigator and sponsor's medical monitor if considered not to interfere with the aims of the study.
• Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
• Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations, gastric pH modifiers, and neutralizing antacids within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee).

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (1)

Labcorp Clinical Research Unit, Madison site

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Blanchard

  Covance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 16, 2021
• Study Start: September 24, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

US (1)