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Trial record 3 of 5 for:    ZN-c5

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04561752
Recruitment Status : Completed
First Posted : September 24, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Zeno Alpha Inc.

Tracking Information
First Submitted Date  ICMJE September 18, 2020
First Posted Date  ICMJE September 24, 2020
Last Update Posted Date December 23, 2020
Actual Study Start Date  ICMJE November 2, 2020
Actual Primary Completion Date December 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Food Effect Study With ZN-c5 in Healthy Post-Menopausal Subjects
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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  ICMJE Healthy
Intervention  ICMJE Drug: ZN-c5
ZN-c5 is the study drug.
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2020)
20
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2020)
18
Actual Study Completion Date  ICMJE December 16, 2020
Actual Primary Completion Date December 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04561752
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Zeno Alpha Inc.
Study Sponsor  ICMJE Zeno Alpha Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Dimitris Voliotis Zeno Alpha Inc.
PRS Account Zeno Alpha Inc.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP