A Food Effect Study With ZN-c5 in Healthy Post-Menopausal Subjects

Healthy Clinical Trial

Official title:

A Randomized, Open-Label, 2-Way Crossover, Single-Dose Food Effect Study of ZN-c5 in Healthy Adult Post-Menopausal Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04561752
• Other study ID #: ZN-c5-006
• Status: Completed
• Phase: Phase 1
• Start date: November 2, 2020
• Est. completion date: December 16, 2020

Study information

• Verified date: December 2020
• Source: Zeno Alpha Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 16, 2020
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ZN-c5
ZN-c5 is the study drug.

Locations

Country	Name	City	State
New Zealand	Site 1	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Zeno Alpha Inc.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t	Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time	Days 1-4
Primary	Cmax	Maximum concentration	Days 1-4
Primary	Tmax	Time to maximum concentration	Days 1-4
Primary	AUC0-infinity	Area under the plasma concentration-time curve (AUC) from time zero to infinity	Days 1-4
Secondary	Assess the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs)	Safety and tolerability of ZN-c5	Approximately 45 days