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Healthy VolunteersPhase 1NCT05159895

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

A Phase 1 study testing [14C]-DZD9008 in people with Healthy Volunteers, run by Dizal Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
[14C]-DZD9008
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
24 Sep 2021to 30 Mar 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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).
  • Subjects will avoid the use of any prescription or nonprescription medications/products or herbal remedies that are strong/moderate CYP3A inhibitors or inducers within 28 days prior to check-in through the end of study, unless deemed acceptable by the Investigator.
  • Subjects will avoid the use of any prescription or nonprescription medications/products or herbal remedies that are transporter (eg, P-gp) inhibitors or inducers within 28 days prior to the check-in through the end of study, unless deemed acceptable by the Investigator.
  • Subjects should avoid the use of proton pump inhibitors from 7 days prior to check-in through 5 days postdose. For H2-antagonists or antacids, administration will follow the staggered schedule per protocol.
  • Subjects who received a live or live-attenuated vaccine in the 2 weeks prior to IMP administration.
  • Participation in a clinical study involving administration of an investigational drug (new chemical entity defined as a compound which has not been approved for marketing) or participation in any other clinical study (including methodology studies where no drugs were given) in the past 90 days prior to dosing.
  • Subjects who have participated in any radiolabeled drug studies in the last 12 months prior to check-in.
  • Have previously completed or withdrawn from this study or any other study investigating DZD9008 and have previously received DZD9008.
  • History of alcohol abuse or excessive alcohol consumption, defined as > 21 units per week for males. One unit of alcohol equals 8.5 oz (250 mL) beer, 0.85 oz (25 mL) liquor, or 2.4 oz (125 mL) wine.
  • Positive urine drug detected at screening, positive urinary alcohol test result or positive urine drug detected at check-in.
  • History or suspected history of alcoholism or drug/chemical abuse within 2 years prior to check-in, as judged by the investigator (or designee).
  • Use of tobacco- or nicotine-containing products within 3 months prior to check-in, or positive cotinine at screening or check-in.
  • Ingestion of poppy seed-, Seville orange-, or grapefruit-containing foods or beverages within 7 days prior to check-in.
  • Receipt of blood products within 2 months prior to check-in.
  • Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, platelets from 6 weeks prior to screening, or any blood loss greater than 500 mL during the 3 months prior to screening.
  • Poor peripheral venous access.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Labcorp Clinical Research Unit, Madison site

    Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Phase 1, Single-Center, Nonrandomized, Open-label Pharmacokinetic and Mass Balance Study of Oral-Administrated [14C]-DZD9008 in Healthy Male Subjects

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

Read the detailed description

Phase 1 study to evaluate the excretion of DZD9008 radioactive dose, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C]-DZD9008 in healthy male subjects. The purpose of this study is to investigate ADME properties of DZD9008 by analyzing blood, urine and feces samples collected during the study

Being tested
[14C]-DZD9008

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]-DZD9008Drug

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

Study groups in NCT05159895
Study groupRoleWhat they receive
[14C]-DZD9008ExperimentalA Single dose of [14C]-DZD9008
Receives: Drug: [14C]-DZD9008

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 85 days

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

    Measured: Up to 85 days

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

    Measured: Up to 85 days

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

    Measured: Up to 85 days

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

    Measured: Up to 85 days

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

    Measured: Up to 85 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start24 Sep 2021
  3. Primary completion30 Mar 2022
  4. Study completion30 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05159895
Sponsor's protocol ID
DZ2021E0003
Status last verified
May 2022
First submitted
22 Nov 2021
Last updated
25 May 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-DZD9008 in people with Healthy Volunteers, run by Dizal Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Total Radioactivity (Cum% Dose) Recovered in Urine Relative to the Administered Radioactive Dose (time frame: Up to 85 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05159895.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.

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