A Food Effect Study With ZN-c5 in Healthy Post-Menopausal... | NCT04561752

NCT04561752

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ZN-c5	Drug	ZN-c5 is the study drug.	Treatment Sequence A-B Treatment Sequence B-A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Assess the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs)	Safety and tolerability of ZN-c5	Approximately 45 days

Eligibility Module

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