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OpenTrials
Completed

NCT Number: NCT05162222

A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose 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.

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Key information

Conditions

Healthy Participants

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit - Dallas

Dallas, Texas, 75247-4968, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Danicamtiv

Drug

Specified dose on specified days

Itraconazole

Drug

Specified dose on specified days

Diltiazem

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 17 days

  2. Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))

    Time frame: Up to 17 days

  3. 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

Secondary outcomes

  1. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to 17 days

  2. Concentration at 24 hours (C24)

    Time frame: Up to 17 days

  3. Apparent terminal plasma half-life (T-HALF)

    Time frame: Up to 17 days

  4. Incidence of adverse events (AEs)

    Time frame: Up to 28 days

  5. Incidence of serious adverse events (SAEs)

    Time frame: Up to 28 days

  6. Incidence of participants with vital sign abnormalities

    Time frame: Up to 17 days

  7. Incidence of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 17 days

  8. Incidence of participants with physical exam abnormalities

    Time frame: Up to 17 days

  9. Incidence of participants with clinical laboratory abnormalities

    Time frame: Up to 17 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2021
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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