A Food Effect Study With ZN-c5 in Healthy Post-Menopausal Subjects
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|ClinicalTrials.gov Identifier: NCT04561752|
Recruitment Status : Completed
First Posted : September 24, 2020
Last Update Posted : December 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: ZN-c5||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|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)|
|Official Title:||A Randomized, Open-Label, 2-Way Crossover, Single-Dose Food Effect Study of ZN-c5 in Healthy Adult Post-Menopausal Female Subjects|
|Actual Study Start Date :||November 2, 2020|
|Actual Primary Completion Date :||December 11, 2020|
|Actual Study Completion Date :||December 16, 2020|
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.
ZN-c5 is the study drug.
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.
ZN-c5 is the study drug.
- 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
- Assess the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Approximately 45 days ]Safety and tolerability of ZN-c5
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04561752
|Christchurch, New Zealand, 8011|
|Study Chair:||Dimitris Voliotis||Zeno Alpha Inc.|