NCT02680782

A Study Comparing Once-Daily vs. Twice-Daily Dosing of X4P-001 in Healthy Volunteers

A Phase 1 Study Comparing Once-Daily vs. Twice-Daily Dosing of X4P-001 in Healthy Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: X4 Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety, tolerability and pharmacokinetics of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily. This study will also assess the pharmacodynamic effects of X4P-001 administered as 200 mg twice daily compared with 400 mg once daily on levels of circulating white blood cells (total and by cell type).

Detailed description

This study will be conducted in 15 healthy volunteers at a clinical research unit located in Daytona Beach, Florida. Screening will be done within 35 days prior to the first dose of study drug (first Dosing Period). Each subject will complete two 10-day Dosing Periods, one using once daily dosing and the other twice daily dosing. The interval between the Dosing Periods will be 7 to 17 days. Patients will be randomly assigned to which regimen is administered the first Dosing Period. Safety laboratory tests will be performed at screening, and prior to and after each Dosing Period. End-of-Study (EOS) visit, the final study event, will be performed 14 to 21 days after the last dose of study drug.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	X4P-001	100 mg capsules, administered orally for 10 days either as 200 mg BID or 400 mg QD. Subjects will be randomized to determine if they will receive the drug QD or BID in the first dosing period.

Timeline

• Start date: 2016-01-12
• Primary completion: 2016-02-28
• Completion: 2016-02-28
• First posted: 2016-02-12
• Last updated: 2018-12-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study