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

NCT04561752 | Completed Phase 1 FDA Drug

• 1 other identifier: ZN-c5-006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Assess the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs)

  Approximately 45 days

Study Arms (2)

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.

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.

Drug: ZN-c5

Interventions

ZN-c5 DRUG

ZN-c5 is the study drug.

Treatment Sequence A-B; Treatment Sequence B-A

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zeno Alpha Inc.: lead

Study Sites (1)

Site 1

Christchurch, 8011, New Zealand

Location

Study Officials

• Dimitris Voliotis

  Zeno Alpha Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will receive the same treatment but are randomized to one of two different treatment sequences in fed and fasted states.

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: November 2, 2020
• Primary Completion: December 11, 2020
• Study Completion: December 16, 2020
• Last Updated: December 23, 2020

Record last verified: 2020-12

Locations

NZ (1)