- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04909242
Assessing the Safety, Tolerability and Pharmacokinetics(PK) of DZD9008 and the Effect of Low-fat Meal on PK of DZD9008 in Healthy Adult Participants
May 28, 2022 updated by: Dizal Pharmaceuticals
A Phase 1 Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of DZD9008 Following Single Ascending Dose and the Effect of Low-fat Meal on Pharmacokinetics of DZD9008 in Healthy Adult Participants
This is a Phase 1, randomised, double-blind, placebo-controlled, single ascending dose sequential group study in healthy participants.
This study consists of three parts: Part A (single dose escalation, SAD) , Part B (food effect, FE) and Part C (relative bioavailability, BA).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Lenexa, Kansas, United States, 66219
- PRA Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants must be able to understand the nature of the trial and provide a signed and dated, written informed consent form before any study-specific procedures, sampling and analyses.
- Provision of signed and dated written Optional Genetic Research informed consent prior to collection of samples for optional genetic research.
- Healthy male or female participants aged 18 to 60 years (inclusive), with BMI 18.0 to 30.0 kg/m2 (inclusive). Body weight: ≥ 55 kg for male, ≥ 45 kg for female.
- Healthy participants defined as the absence of acute or chronic clinically significant deviations from normal in medical history, physical examination, visual assessment, electrocardiogram (ECG), and clinical laboratory determinations at screening.
- Participants must agree to practice effective contraception.
- Normal baseline PFTs (≥ 80% predicted normal for spirometry, lung volumes).
- Normal baseline ECG (QTcF < 450 msec, PR < 210 msec).
- Non-smoker (not smoked within 3 months).
- Liver biochemistry parameters: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN
- Adequate organ function including hepatic, renal, cardiac, visual and bone marrow function as determined by the investigator.
Exclusion Criteria:
- Ongoing or prior pulmonary disease including asthma, chronic obstructive pulmonary disease, interstitial lung disease and pneumonitis including but not limited to drug-related pneumonitis.
- Women who are breast feeding.
- Positive pregnancy test prior to study entry.
- History of malignancy of any type, with the exception of the following: surgically excised non-melanomatous skin cancers more than 5 years prior to receiving IP.
- A history of additional risk factors for TdP (e.g. heart failure, hypokalemia, family history of Long QT syndrome).
- No prior history of atrial fibrillation within 6 months prior to first dosing of DZD9008
- Manifestations of malabsorption due to prior GI surgery, GI disease, or for an unknown other reason that may affect the absorption of DZD9008-. Pulmonary infections or other active infection within 30 days of informed consent
- History of bleeding disorder (including hemophilia, Von Willebrand disease, etc), history of stroke or intracranial haemorrhage within 6 months before study drug administration.
- Judgement by the investigator that the participant is not likely to comply with study procedures, restrictions and requirements.
- Positive serology or a known history of hepatitis B virus (HBV), hepatitis C virus (HCV), HIV.
- Resting blood pressure > 140/90 mmHg at screening .
- Resting pulse rate < 45 beats per minute.
- History of severe allergy or hypersensitivity reaction or ongoing allergy or hypersensitivity reaction, as judged by investigator, or history of hypersensitivity to EGFR/HER2/BTK inhibitors.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: single oral dose of DZD9008
single dose of DZD9008 (50 mg, 100 mg, 200 mg, 300 mg and 400 mg, tablet)
|
In the double blind, randomised, placebo-controlled trial (Part A - SAD), healthy adult participants will be randomized to receive DZD9008 at different dose levels.
There are 5 planned dose cohorts, starting from 50 mg once daily.
If tolerated, subsequent cohorts will test increasing doses of DZD9008 or matching placebo, namely 100 mg, 200 mg, 300 mg and 400 mg.
In Part C, healthy adult participants will be enrolled to receive a single dose of DZD9008 as suspension in period 1 and as tablet in period 2.
Healthy adult participants will be randomized to receive DZD9008 single dose at a defined dose under a cross-over condition with or without food (low-fat in Part B; high-fat in Part D).
|
PLACEBO_COMPARATOR: single oral dose of placebo
single dose of placebo (matching placebo, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg, tablet)
|
In the double blind, randomised, placebo-controlled trial (Part A - SAD), healthy adult participants will be randomized to receive matching placebo for DZD9008 at different dose levels.
There are 5 planned dose cohorts of matching placebo for DZD9008, starting from 50 mg once daily.
|
EXPERIMENTAL: single oral dose of DZD9008 (300 mg, tablet)
|
In the double blind, randomised, placebo-controlled trial (Part A - SAD), healthy adult participants will be randomized to receive DZD9008 at different dose levels.
There are 5 planned dose cohorts, starting from 50 mg once daily.
If tolerated, subsequent cohorts will test increasing doses of DZD9008 or matching placebo, namely 100 mg, 200 mg, 300 mg and 400 mg.
In Part C, healthy adult participants will be enrolled to receive a single dose of DZD9008 as suspension in period 1 and as tablet in period 2.
Healthy adult participants will be randomized to receive DZD9008 single dose at a defined dose under a cross-over condition with or without food (low-fat in Part B; high-fat in Part D).
|
EXPERIMENTAL: single oral dose of DZD9008 (100 mg, tablet or suspension)
|
In the double blind, randomised, placebo-controlled trial (Part A - SAD), healthy adult participants will be randomized to receive DZD9008 at different dose levels.
There are 5 planned dose cohorts, starting from 50 mg once daily.
If tolerated, subsequent cohorts will test increasing doses of DZD9008 or matching placebo, namely 100 mg, 200 mg, 300 mg and 400 mg.
In Part C, healthy adult participants will be enrolled to receive a single dose of DZD9008 as suspension in period 1 and as tablet in period 2.
Healthy adult participants will be randomized to receive DZD9008 single dose at a defined dose under a cross-over condition with or without food (low-fat in Part B; high-fat in Part D).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: up to 14 days after study drug administration
|
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
|
up to 14 days after study drug administration
|
Number of participants with clinically significant laboratory assessment abnormalities
Time Frame: up to 14 days after study drug administration
|
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
|
up to 14 days after study drug administration
|
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time Frame: up to 14 days after study drug administration
|
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
|
up to 14 days after study drug administration
|
Number of participants with clinically significant abnormalities in LVEF
Time Frame: up to 14 days after study drug administration
|
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
|
up to 14 days after study drug administration
|
Number of participants with clinically significant abnormalities in FEV1%
Time Frame: up to 14 days after study drug administration
|
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
|
up to 14 days after study drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum plasma concentration (Cmax) of DZD9008
Time Frame: up to 10 days after study drug administration
|
up to 10 days after study drug administration
|
Time to reach maximum plasma concentration (tmax)
Time Frame: up to 10 days after study drug administration
|
up to 10 days after study drug administration
|
Area under the concentration-time curve from time 0 (pre-dose) to the time of the dosing interval (AUC0-t)
Time Frame: up to 10 days after study drug administration
|
up to 10 days after study drug administration
|
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Time Frame: up to 10 days after study drug administration
|
up to 10 days after study drug administration
|
Apparent total plasma clearance (CL/F)
Time Frame: up to 10 days after study drug administration
|
up to 10 days after study drug administration
|
Apparent volume of distribution (Vz/F)
Time Frame: up to 10 days after study drug administration
|
up to 10 days after study drug administration
|
Mean residence time (MRT)
Time Frame: up to 10 days after study drug administration
|
up to 10 days after study drug administration
|
Terminal elimination half-life (t1/2)
Time Frame: up to 10 days after study drug administration
|
up to 10 days after study drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Dickerson, PRA Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 21, 2021
Primary Completion (ACTUAL)
February 7, 2022
Study Completion (ACTUAL)
February 7, 2022
Study Registration Dates
First Submitted
May 13, 2021
First Submitted That Met QC Criteria
May 24, 2021
First Posted (ACTUAL)
June 1, 2021
Study Record Updates
Last Update Posted (ACTUAL)
June 2, 2022
Last Update Submitted That Met QC Criteria
May 28, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- DZ2021E0004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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