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

August 9, 2022 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75247-4968
        • Covance Clinical Research Unit - Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Danicamtiv, followed by itraconazole + danicamtiv
Drug: Itraconazole
Specified dose on specified days
Drug: Danicamtiv
Specified dose on specified days
EXPERIMENTAL: Danicamtiv, followed by diltiazem + danicamtiv
Drug: Danicamtiv
Specified dose on specified days
Drug: Diltiazem
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 17 days
Up to 17 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
Time Frame: Up to 17 days
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))
Time Frame: Up to 17 days
Up to 17 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs)
Time Frame: Up to 28 days
Up to 28 days
Incidence of serious adverse events (SAEs)
Time Frame: Up to 28 days
Up to 28 days
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to 17 days
Up to 17 days
Concentration at 24 hours (C24)
Time Frame: Up to 17 days
Up to 17 days
Apparent terminal plasma half-life (T-HALF)
Time Frame: Up to 17 days
Up to 17 days
Incidence of participants with vital sign abnormalities
Time Frame: Up to 17 days
Up to 17 days
Incidence of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 17 days
Up to 17 days
Incidence of participants with physical exam abnormalities
Time Frame: Up to 17 days
Up to 17 days
Incidence of participants with clinical laboratory abnormalities
Time Frame: Up to 17 days
Up to 17 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 15, 2021

Primary Completion (ACTUAL)

July 8, 2022

Study Completion (ACTUAL)

July 8, 2022

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

December 9, 2021

First Posted (ACTUAL)

December 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV028-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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