Status:
COMPLETED
Assessing the Safety, Tolerability and Pharmacokinetics(PK) of DZD9008 and the Effect of Low-fat Meal on PK of DZD9008 in Healthy Adult Participants
Lead Sponsor:
Dizal Pharmaceuticals
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 escalatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2022
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04909242
Start Date
April 21 2021
End Date
February 7 2022
Last Update
June 2 2022
Active Locations (1)
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1
PRA Health Sciences
Lenexa, Kansas, United States, 66219