NCT03498170

The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants

An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Mereo BioPharma · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants.

Detailed description

This will be an open label study conducted in healthy male participants at a single centre. Each participant will participate in a screening visit and 2 study periods. At the first study period, all participants will receive a single dose of BCT197 and at study period 2, all participants will receive 14 daily doses of itraconazole and a single dose of BCT197.

Conditions

• Interaction

Interventions

Type	Name	Description
DRUG	BCT197	Single dose of BCT197
DRUG	Itraconazole 200 mg	Single dose of itraconazole

Timeline

• Start date: 2018-03-19
• Primary completion: 2018-05-03
• Completion: 2018-05-09
• First posted: 2018-04-13
• Last updated: 2018-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study