NCT05162222

A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose of Danicamtiv in Healthy Participants

An Open-label, Randomized, 2-Period Crossover Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose Pharmacokinetics of Danicamtiv in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effects of co-administration of itraconazole or diltiazem on the single-dose pharmacokinetics of danicamtiv in healthy participants.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Danicamtiv	Specified dose on specified days
DRUG	Itraconazole	Specified dose on specified days
DRUG	Diltiazem	Specified dose on specified days

Timeline

• Start date: 2021-12-15
• Primary completion: 2022-07-08
• Completion: 2022-07-08
• First posted: 2021-12-17
• Last updated: 2022-08-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study