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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ZN-c5

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8011
    • Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Sequence A-B; 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.	Drug: ZN-c5; ZN-c5 is the study drug.
Experimental: Treatment Sequence B-A; 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.	Drug: ZN-c5; ZN-c5 is the study drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-t	Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time	Days 1-4
Cmax	Maximum concentration	Days 1-4
Tmax	Time to maximum concentration	Days 1-4
AUC0-infinity	Area under the plasma concentration-time curve (AUC) from time zero to infinity	Days 1-4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs)	Safety and tolerability of ZN-c5	Approximately 45 days

Collaborators and Investigators

• Sponsor: Zeno Alpha Inc.
• Investigators: Study Chair: Dimitris Voliotis, Zeno Alpha Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): December 11, 2020
• Study Completion (Actual): December 16, 2020

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 22, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Randomized; Female; Postmenopause
• Other Study ID Numbers: ZN-c5-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No