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
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2021
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2021
CompletedStudy Start
First participant enrolled
December 15, 2021
CompletedFirst Posted
Study publicly available on registry
December 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2022
CompletedAugust 10, 2022
July 1, 2022
7 months
December 9, 2021
August 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax)
Up to 17 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
Up to 17 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T))
Up to 17 days
Secondary Outcomes (9)
Time of maximum observed plasma concentration (Tmax)
Up to 17 days
Concentration at 24 hours (C24)
Up to 17 days
Apparent terminal plasma half-life (T-HALF)
Up to 17 days
Incidence of adverse events (AEs)
Up to 28 days
Incidence of serious adverse events (SAEs)
Up to 28 days
- +4 more secondary outcomes
Study Arms (2)
Danicamtiv, followed by itraconazole + danicamtiv
EXPERIMENTALDanicamtiv, followed by diltiazem + danicamtiv
EXPERIMENTALInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- Body mass index between 18 and 30 kg/m\^2, inclusive, at the Screening Visit
- Normal ECG at the Screening Visit
- Normal renal function at Screening
You may not qualify if:
- History of ventricular arrhythmias
- History of heart disease or conduction disorders
- History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study intervention administration)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance Clinical Research Unit - Dallas
Dallas, Texas, 75247-4968, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2021
First Posted
December 17, 2021
Study Start
December 15, 2021
Primary Completion
July 8, 2022
Study Completion
July 8, 2022
Last Updated
August 10, 2022
Record last verified: 2022-07