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

• ClinicalTrials.gov Identifier: NCT04561752
• Recruitment Status: Completed
• First Posted: September 24, 2020
• Last Update Posted: December 23, 2020
• Sponsor: Zeno Alpha Inc.
• Information provided by (Responsible Party): Zeno Alpha Inc.

Tracking Information

• First Submitted Date: September 18, 2020
• First Posted Date: September 24, 2020
• Last Update Posted Date: December 23, 2020
• Actual Study Start Date: November 2, 2020
• Actual Primary Completion Date: December 11, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 22, 2020)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 22, 2020)

Assess the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Approximately 45 days ]

Safety and tolerability of ZN-c5

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
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.

Masking: None (Open Label)
Primary Purpose: Other

• Condition: Healthy

Intervention

Drug: ZN-c5

ZN-c5 is the study drug.

Study Arms

• 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.
  Intervention: Drug: ZN-c5
• 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.
  Intervention: Drug: ZN-c5

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 22, 2020): 20
• Original Estimated Enrollment (submitted: September 22, 2020): 18
• Actual Study Completion Date: December 16, 2020
• Actual Primary Completion Date: December 11, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 45 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: New Zealand

Administrative Information

• NCT Number: NCT04561752
• Other Study ID Numbers: ZN-c5-006
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Zeno Alpha Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Zeno Alpha Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Dimitris Voliotis; Zeno Alpha Inc.

• PRS Account: Zeno Alpha Inc.
• Verification Date: December 2020