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OpenTrials
Completed

NCT Number: NCT04561752

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

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Key information

Conditions

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Site 1

Christchurch, 8011, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZN-c5

Drug

ZN-c5 is the study drug.

Primary outcomes

  1. AUC0-t

    Time frame: Days 1-4

    Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time

  2. Cmax

    Time frame: Days 1-4

    Maximum concentration

  3. Tmax

    Time frame: Days 1-4

    Time to maximum concentration

  4. AUC0-infinity

    Time frame: Days 1-4

    Area under the plasma concentration-time curve (AUC) from time zero to infinity

Secondary outcomes

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

    Time frame: Approximately 45 days

    Safety and tolerability of ZN-c5

Sponsors and collaborators

Lead sponsor

Zeno Alpha Inc.

Industry

Registry information

Official study title

A Randomized, Open-Label, 2-Way Crossover, Single-Dose Food Effect Study of ZN-c5 in Healthy Adult Post-Menopausal Female Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2020
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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