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

NCT ID: NCT05162222

Last Updated: 2022-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2022-07-08

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Danicamtiv, followed by itraconazole + danicamtiv

Group Type EXPERIMENTAL

Danicamtiv

Intervention Type DRUG

Specified dose on specified days

Itraconazole

Intervention Type DRUG

Specified dose on specified days

Danicamtiv, followed by diltiazem + danicamtiv

Group Type EXPERIMENTAL

Danicamtiv

Intervention Type DRUG

Specified dose on specified days

Diltiazem

Intervention Type DRUG

Specified dose on specified days

Interventions

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Danicamtiv

Specified dose on specified days

Intervention Type DRUG

Itraconazole

Specified dose on specified days

Intervention Type DRUG

Diltiazem

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Covance Clinical Research Unit - Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CV028-008

Identifier Type: -

Identifier Source: org_study_id

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