HealthyPhase 1NCT04561752
A Food Effect Study With ZN-c5 in Healthy Post-Menopausal Subjects
A Phase 1 study testing ZN-c5 in people with Healthy, run by Zeno Alpha Inc. at 1 site in New Zealand.
Trial summary
This is a single-center, randomized, open-label, two-period, 2-way crossover food effect study to determine the comparative bioavailability of ZN-c5 under fed and fasting conditions, following single-dose administration of ZN-c5 capsules (150mg). Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ZN-c5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNew Zealand
- Study dates
- 2 Nov 2020to 16 Dec 2020
- 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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female volunteers
- Body mass index (BMI) between > or = 18.0 kg/m2 and < or = 29.9 kg/m2, and a body weight > or = 50kg and < or = 100kg at Screening
- Non-smoker and must not have used any tobacco products within 2 months prior to Screening, or if a smoker must be currently (and for the last 2 months prior to screening) smoking < or = 2 cigarettes or equivalent per week. Current smokers must be willing to abstain from the use of tobacco and products containing nicotine from 14 days prior to administration of study drug and through the EOS visit.
- No relevant dietary restrictions, and be willing to consume a high calorie, high fat breakfast and other standard meals provided during the domiciled periods of the study
- Post-menopausal for > or = 24 months. Status will be confirmed through testing of follicle-stimulating hormone (FSH) levels > or = 40 IU/L at Screening. Participants that are post-menopausal for < or = 24 months are still potentially eligible, but will be required to have a negative serum pregnancy test result at Screening and negative urine pregnancy test result prior to study drug administration.
Who cannot join
- Any condition likely to affect the participant's ability to consume the standard meal provided during the domiciled periods of the study, or any condition that may make it difficult for the patient to comply with the requirement for fasting during the study
- Blood donation or significant blood loss within 60 days prior to the first study drug administration
- Plasma donation within 7 days prior to the first study drug administration
- Fever (body temperature > or = 38C) or symptomatic viral or bacterial infection or febrile illness within 2 weeks prior to Screening
- Positive serum pregnancy test at Screening or urine pregnancy test prior to administration of study drug (for participants who are post-menopausal for < or = 24 months only)
- Positive toxicology screening panel or alcohol breath test
- History of substance abuse or dependency or history of recreational intravenous (IV) drug use over the last 5 years (by self-declaration)
- Regular alcohol consumption within the 6 months prior to study drug administration, defined as > 21 alcohol units per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, 2-Way Crossover, Single-Dose Food Effect Study of ZN-c5 in Healthy Adult Post-Menopausal Female Subjects
This is a single-center, randomized, open-label, two-period, 2-way crossover food effect study to determine the comparative bioavailability of ZN-c5 under fed and fasting conditions, following single-dose administration of ZN-c5 capsules (150mg).
- Conditions
- Healthy
- Being tested
- ZN-c5
- Keywords
- Randomized, Postmenopause, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZN-c5Drug
ZN-c5 is the study drug.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence A-B | Experimental | Participants will take ZN-c5 (150mg), single dose, under fasted conditions, and a week later, will take the same drug under fed conditions to determine the comparative bioavailability of ZN-c5 under these conditions. Receives: Drug: ZN-c5 |
| Treatment Sequence B-A | Experimental | Participants will take ZN-c5 (150mg), single dose, under fed conditions, and a week later, will take the same drug under fasted conditions to determine the comparative bioavailability of ZN-c5 under these conditions. Receives: Drug: ZN-c5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time
Measured: Days 1-4
Cmax
Maximum concentration
Measured: Days 1-4
Tmax
Time to maximum concentration
Measured: Days 1-4
AUC0-infinity
Area under the plasma concentration-time curve (AUC) from time zero to infinity
Measured: Days 1-4
Secondary outcomes (1)
Assess the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs)
Safety and tolerability of ZN-c5
Measured: Approximately 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start2 Nov 2020
- Primary completion11 Dec 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will receive the same treatment but are randomized to one of two different treatment sequences in fed and fasted states.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeno Alpha Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dimitris Voliotis, Study chair, Zeno Alpha Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561752
- Sponsor's protocol ID
- ZN-c5-006
- Status last verified
- Dec 2020
- First submitted
- 18 Sep 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, 2-Way Crossover, Single-Dose Food Effect Study of ZN-c5 in Healthy Adult Post-Menopausal Female Subjects
- ClinicalTrials.gov ID
- NCT04561752
- Acronym / sponsor ID
- ZN-c5-006
- Conditions
- Healthy
- Keywords
- Randomized, Postmenopause, Female
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zeno Alpha Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, randomized, open-label, two-period, 2-way crossover food effect study to determine the comparative bioavailability of ZN-c5 under fed and fasting conditions, following single-dose administration of ZN-c5 capsules (150mg).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will receive the same treatment but are randomized to one of two different treatment sequences in fed and fasted states.
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence A-B | Experimental | Drug: ZN-c5Participants will take ZN-c5 (150mg), single dose, under fasted conditions, and a week later, will take the same drug under fed conditions to determine the comparative bioavailability of ZN-c5 under these conditions. |
| Treatment Sequence B-A | Experimental | Drug: ZN-c5Participants will take ZN-c5 (150mg), single dose, under fed conditions, and a week later, will take the same drug under fasted conditions to determine the comparative bioavailability of ZN-c5 under these conditions. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy female volunteers
- Body mass index (BMI) between > or = 18.0 kg/m2 and < or = 29.9 kg/m2, and a body weight > or = 50kg and < or = 100kg at Screening
- Non-smoker and must not have used any tobacco products within 2 months prior to Screening, or if a smoker must be currently (and for the last 2 months prior to screening) smoking < or = 2 cigarettes or equivalent per week. Current smokers must be willing to abstain from the use of tobacco and products containing nicotine from 14 days prior to administration of study drug and through the EOS visit.
- No relevant dietary restrictions, and be willing to consume a high calorie, high fat breakfast and other standard meals provided during the domiciled periods of the study
- Post-menopausal for > or = 24 months. Status will be confirmed through testing of follicle-stimulating hormone (FSH) levels > or = 40 IU/L at Screening. Participants that are post-menopausal for < or = 24 months are still potentially eligible, but will be required to have a negative serum pregnancy test result at Screening and negative urine pregnancy test result prior to study drug administration.
Key exclusion criteria (8 listed)
- Any condition likely to affect the participant's ability to consume the standard meal provided during the domiciled periods of the study, or any condition that may make it difficult for the patient to comply with the requirement for fasting during the study
- Blood donation or significant blood loss within 60 days prior to the first study drug administration
- Plasma donation within 7 days prior to the first study drug administration
- Fever (body temperature > or = 38C) or symptomatic viral or bacterial infection or febrile illness within 2 weeks prior to Screening
- Positive serum pregnancy test at Screening or urine pregnancy test prior to administration of study drug (for participants who are post-menopausal for < or = 24 months only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZN-c5ZN-c5 is the study drug. | Drug | Treatment Sequence A-B, Treatment Sequence B-A |
Primary outcome
AUC0-t
Time frame: Days 1-4
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time
Cmax
Time frame: Days 1-4
Maximum concentration
Tmax
Time frame: Days 1-4
Time to maximum concentration
AUC0-infinity
Time frame: Days 1-4
Area under the plasma concentration-time curve (AUC) from time zero to infinity
1 secondary outcome
Assess the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs)
Time frame: Approximately 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitris Voliotis study chair
Zeno Alpha Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZN-c5 in people with Healthy, run by Zeno Alpha 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 5 inclusion and 8 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 23 Dec 2020. 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?
AUC0-t (time frame: Days 1-4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2020.