Clinical trial NCT04561752: A Food Effect Study With ZN-c5 in Healthy Post-Menopausal Subjects
Official title: A Randomized, Open-Label, 2-Way Crossover, Single-Dose Food Effect Study of ZN-c5 in Healthy Adult Post-Menopausal Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Randomized
Postmenopause
Female
Lead sponsor: Zeno Alpha Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will receive the same treatment but are randomized to one of two different treatment sequences in fed and fasted states.
Primary purpose: OTHER

Brief 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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: AUC0-t
timeFrame: Days 1-4
measure: Cmax
timeFrame: Days 1-4
measure: Tmax
timeFrame: Days 1-4
measure: AUC0-infinity
timeFrame: Days 1-4
Secondary outcomes:
measure: Assess the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs)
timeFrame: Approximately 45 days
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: Site 1
Study officials:
affiliation: Zeno Alpha Inc.
name: Dimitris Voliotis
role: STUDY_CHAIR
References: