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

NCT ID: NCT04561752

Last Updated: 2020-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2020-12-16

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).

Conditions

Healthy

Keywords

Randomized; Postmenopause; Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ZN-c5

Intervention Type: DRUG

ZN-c5 is the study drug.

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.

Group Type: EXPERIMENTAL

ZN-c5

Intervention Type: DRUG

ZN-c5 is the study drug.

Interventions

ZN-c5

ZN-c5 is the study drug.

Intervention Type: DRUG

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Zeno Alpha Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dimitris Voliotis

Role: STUDY_CHAIR

Zeno Alpha Inc.

Locations

Site 1

Christchurch, , New Zealand

Countries

New Zealand

Other Identifiers

ZN-c5-006

Identifier Type: -

Identifier Source: org_study_id