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Healthy VolunteersPhase 1NCT04854174

A Food Effect Study of ZN-d5 in Healthy Female Volunteers

A Phase 1 study testing ZN-d5 in people with Healthy Volunteers, run by K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. at 1 site in New Zealand.

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 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
ZN-d5
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteNew Zealand
Study dates
13 Jun 2021to 5 Jul 2021
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 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy females, age 18-65 years;
  • Body mass index (BMI) ≥ 18.0 and ≤ 29.9 kg/m2 and weight ≥ 50 kg and ≤ 100 kg at Screening;
  • 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;
  • 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;
  • 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;
  • Able to take and retain oral medications;
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  • 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;
  • Negative serum pregnancy test; i.e., beta-human chorionic gonadotropin (β-hCG) test at Screening and negative urine pregnancy test prior to administration of study drug (unless post-menopausal status is FSH-confirmed);
  • Must have the ability and willingness to attend the necessary visits to the study center and to be domiciled overnight where required;
  • Provides written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures;
  • Baseline B lymphocyte count >150 cells/µL (0.15 x109 cells/L).

Who cannot join

  • Any condition possibly affecting drug absorption (e.g., gastrectomy, gastric banding, or gastric bypass);
  • 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;
  • 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;
  • 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;
  • Fever (body temperature ≥38°C) or symptomatic viral or bacterial infection or febrile illness within 2 weeks prior to Screening;
  • 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;
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  • 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;
  • Other abnormal ECG findings at Screening that are considered by the investigator to be clinically significant;
  • 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;
  • Estimated glomerular filtration rate by CKD-EPI <60 mL/min/1.73 m2
  • 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;
  • Positive serology test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening;
  • Positive urine toxicology screening panel or alcohol breath test;
  • History of substance abuse or dependency or history of recreational intravenous drug use over the last 5 years (by self-declaration);
  • 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);
  • 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;
  • 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;
  • 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;
  • Unwilling or unable to comply with the lifestyle guidelines outlined in the protocol.

Trial locations and contacts

1 site in 1 country.

New Zealand1 site

  • Site # 2801

    Christchurch

Other trials in New Zealand

About this study

Official title: An Open-Label Food Effect Study of ZN-d5 in Healthy Female Volunteers

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.

Read the detailed description

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.

Being tested
ZN-d5
Keywords
Healthy Volunteers

What participants receive

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

  • ZN-d5Drug

    Also called Study Drug

    Oral agent; 25 mg formulation

Study groups in NCT04854174
Study groupRoleWhat they receive
Healthy VolunteerExperimentalHealthy Volunteer
Receives: Drug: ZN-d5

What is being measured

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

  1. ZN-d5 Bioavailability

    Maximum concentration (Cmax)

    Measured: 2 months

  2. ZN-d5 Bioavailability

    Area under the plasma concentration-time curve (AUC)

    Measured: 2 months

Secondary outcomes (6)

  1. Safety and Tolerability of ZN-d5

    The incidence, frequency and severity of treatment-emergent adverse events (TEAEs)

    Measured: 2 Months

  2. Safety and Tolerability of ZN-d5

    time to maximum concentration

    Measured: 2 months

  3. Safety and Tolerability of ZN-d5

    delay in achieving Tmax (tlag)

    Measured: 2 Months

  4. Safety and Tolerability of ZN-d5

    Half-life (t1/2)

    Measured: 2 Months

  5. Safety and Tolerability of ZN-d5

    Volume of distribution (Vs/F)

    Measured: 2 months

  6. Safety and Tolerability of ZN-d5

    Clearance (CL/F)

    Measured: 2 months

Timeline

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

  1. First posted22 Apr 2021
  2. Study start13 Jun 2021
  3. Primary completion30 Jun 2021
  4. Study completion5 Jul 2021

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04854174
Sponsor's protocol ID
ZN-d5-002
Status last verified
Sep 2024
First submitted
17 Mar 2021
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ZN-d5 in people with Healthy Volunteers, run by K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. at 1 site in New Zealand.

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 11 inclusion and 20 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 19 Sep 2024. 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 New Zealand. 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?

ZN-d5 Bioavailability (time frame: 2 months). The study lists 2 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 NCT04854174.

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 19 Sep 2024.

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