NCT04854174

A Food Effect Study of ZN-d5 in Healthy Female Volunteers

An Open-Label Food Effect Study of ZN-d5 in Healthy Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, sequential, open-label, food effect study to determine the comparative bioavailability of ZN-d5 under fasting and fed conditions, following single-dose oral administration of ZN-d5. The study will be comprised of a pre-study screening, followed by administration of a single dose of ZN-d5 under fasted conditions, a washout period, administration of a single dose of ZN-d5 under fed conditions, and a follow-up period.

Detailed description

This is a single-center, sequential, open-label, food effect study to determine the comparative bioavailability of ZN-d5 under fasting and fed conditions, following single-dose oral administration of ZN-d5. The study will be comprised of a pre-study screening, followed by administration of a single dose of ZN-d5 under fasted conditions, a washout period, administration of a single dose of ZN-d5 under fed conditions, and a follow-up period.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ZN-d5	Oral agent; 25 mg formulation

Timeline

• Start date: 2021-06-13
• Primary completion: 2021-06-30
• Completion: 2021-07-05
• First posted: 2021-04-22
• Last updated: 2024-09-19

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study