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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04854174




Registration number
NCT04854174
Ethics application status
Date submitted
17/03/2021
Date registered
22/04/2021
Date last updated
22/04/2021

Titles & IDs
Public title
A Food Effect Study of ZN-d5 in Healthy Female Volunteers
Scientific title
An Open-Label Food Effect Study of ZN-d5 in Healthy Female Volunteers
Secondary ID [1] 0 0
ZN-d5-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZN-d5

Experimental: Healthy Volunteer - Healthy Volunteer


Treatment: Drugs: ZN-d5
Oral agent; 25 mg formulation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
ZN-d5 Bioavailability
Timepoint [1] 0 0
2 months
Primary outcome [2] 0 0
ZN-d5 Bioavailability
Timepoint [2] 0 0
2 months
Secondary outcome [1] 0 0
Safety and Tolerability of ZN-d5
Timepoint [1] 0 0
2 Months
Secondary outcome [2] 0 0
Safety and Tolerability of ZN-d5
Timepoint [2] 0 0
2 months
Secondary outcome [3] 0 0
Safety and Tolerability of ZN-d5
Timepoint [3] 0 0
2 Months
Secondary outcome [4] 0 0
Safety and Tolerability of ZN-d5
Timepoint [4] 0 0
2 Months
Secondary outcome [5] 0 0
Safety and Tolerability of ZN-d5
Timepoint [5] 0 0
2 months
Secondary outcome [6] 0 0
Safety and Tolerability of ZN-d5
Timepoint [6] 0 0
2 months

Eligibility
Key inclusion criteria
1. Healthy females, age 18-65 years;

2. Body mass index (BMI) = 18.0 and = 29.9 kg/m2 and weight = 50 kg and = 100 kg at
Screening;

3. Non-smoker and must not have used any tobacco products within two months prior to
Screening, or if a smoker, must be currently (and for the last two months prior to
screening) smoking = 2 cigarettes or equivalent per week. Participants must be willing
to abstain from the use of tobacco and products containing nicotine from 14 days prior
to administration of study drug for the duration of the study;

4. No relevant dietary restrictions; willing to consume a high calorie, high fat
breakfast and other standard meals provided during the domiciled periods of the study,
to comply with the fasting conditions required by the study design, and to avoid
consumption of grapefruit, carambola (star fruit), pomelo or Seville oranges or their
juices or extracts from 7 days prior to the administration of study drug and for the
duration of the study;

5. Willing to abstain from alcohol beginning 48 hours prior to each admission until
discharge from the study center at the end of each domiciled period;

6. Able to take and retain oral medications;

7. If sexually active and of childbearing potential, must agree to use two effective
methods of contraception beginning at the Screening Visit until 60 days following the
last dose of study drug; egg donation is also prohibited during this period (see
Appendix 14.1). Post-menopausal status to be confirmed with serum follicle-stimulating
hormone (FSH) levels;

8. Negative serum pregnancy test; i.e., beta-human chorionic gonadotropin (ß-hCG) test at
Screening and negative urine pregnancy test prior to administration of study drug
(unless post-menopausal status is FSH-confirmed);

9. Must have the ability and willingness to attend the necessary visits to the study
center and to be domiciled overnight where required;

10. Provides written informed consent after the nature of the study has been explained and
prior to the commencement of any study procedures;

11. Baseline B lymphocyte count >150 cells/µL (0.15 x109 cells/L).
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any condition possibly affecting drug absorption (e.g., gastrectomy, gastric banding,
or gastric bypass);

2. Prior or ongoing medical conditions, medical history, physical findings, or laboratory
abnormality that, in the Investigator's opinion, could adversely affect the safety of
the participant or make it unlikely that the participant will comply with the protocol
or complete the study per protocol;

3. Blood donation or significant blood loss within 60 days prior to the first study drug
administration or plasma donation within 7 days of the administration of study drug;

4. Routine consumption of xanthine-containing products or foods exceeds 800 mg daily
intake of xanthines, continuing to within 7 days of the administration of study drug;

5. Fever (body temperature =38°C) or symptomatic viral or bacterial infection or febrile
illness within 2 weeks prior to Screening;

6. History of recurrent (more than three episodes in 12 months) or chronic infections of
any type, such as tuberculosis, sinusitis, or urinary tract infection, that in the
opinion of the Investigator poses a risk to participate in the study, or any infection
requiring parenteral antibiotics within the six months prior to Screening;

7. 12-lead ECG demonstrating QT interval corrected for heart rate using Fridericia's
formula (QTcF) > 480 msec at the Screening Visit or history/evidence of long QT
syndrome;

8. Other abnormal ECG findings at Screening that are considered by the investigator to be
clinically significant;

9. Alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase
(ALT), and/or total bilirubin > 1.5 × upper limit of normal at screening (elevated
bilirubin acceptable if participant was known to have Gilbert's syndrome). Repeat
testing at Screening is acceptable for out-of-range values following approval by the
Investigator or delegate;

10. Estimated glomerular filtration rate by CKD-EPI <60 mL/min/1.73 m2

11. Pregnant or breast-feeding, or intending to become pregnant, initiate breast-feeding
or donate eggs from Screening until 60 days after the last dose of study drug;

12. Positive serology test for hepatitis C antibody (HCV), hepatitis B surface antigen
(HBsAg), or human immunodeficiency virus (HIV) antibody at Screening;

13. Positive urine toxicology screening panel or alcohol breath test;

14. History of substance abuse or dependency or history of recreational intravenous drug
use over the last 5 years (by self-declaration);

15. Regular alcohol consumption within the 6 months prior to study drug administration,
defined as >14 alcohol units per week (where 1 unit = 284 mL of beer, 25 mL of 40%
spirit or a 125 mL glass of wine);

16. Use of any investigational product within the longer of 28 days or 5 half-lives prior
to administration of study drug or participation in more than four investigational
drug studies within 1 year prior to Screening;

17. Use of any prescription drugs, over-the-counter (OTC) (non-prescription) medication,
herbal remedies (including St John's Wort), supplements or vitamins 14 days prior to
dosing and during the course of study without prior approval of the Investigator and
Sponsor.

Simple analgesia (e.g., paracetamol or OTC nonsteroidal anti-inflammatory drugs) are
permitted in limited doses;

18. Use of strong or moderate inhibitors or inducers of Cytochrome P450 (CYP) 3A,
inhibitors or inducers of P-glycoprotein (P-gp), or drugs known to prolong the QT
interval during the longer of 14 days or five half-lives prior to enrollment and
during the course of the study;

19. Unwilling or unable to comply with the lifestyle guidelines outlined in the protocol.

Study design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
4/06/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a single-center, sequential, open-label, food effect study to determine the
comparative bioavailability of ZN-d5 under fasting and fed conditions, following single-dose
oral administration of ZN-d5. The study will be comprised of a pre-study screening, followed
by administration of a single dose of ZN-d5 under fasted conditions, a washout period,
administration of a single dose of ZN-d5 under fed conditions, and a follow-up period.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04854174
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony Fiorino, MD, PhD
Address 0 0
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anthony Fiorino, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
8582634333
Fax 0 0
Email 0 0
info@zenopharma.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04854174