The Effect of CS-3150 Exposure on Corrected QT (QTc) Interval Duration in Healthy Volunteers

July 12, 2019 updated by: Daiichi Sankyo, Inc.

A Randomized, Double-Blind, Single-Dose, Placebo- and Positive-Controlled Crossover Study to Evaluate the Effect of Therapeutic and Supratherapeutic Exposure to CS-3150 on QTc Interval Duration in Healthy Male and Female Subjects

This study will test if a study drug (CS-3150) will affect the heart rate in healthy males and females. Two doses of the study drug will be tested. Heart rate is not expected to be different between the study groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will assess the effect of therapeutic and supratherapeutic plasma exposures of CS-3150 on the corrected QT (QTc) interval duration after administration of single oral 10-mg and 40-mg doses of CS-3150 in healthy male and female participants. This study will also determine the safety and tolerability of CS-3150 administration, assess the effect on electrocardiogram (ECG) parameters, detect QT interval (QT)/QTc prolongation with a positive control (moxifloxacin), characterize pharmacokinetics (PK) of CS-3150, and assess exposure-response relationship of CS-3150 on QTc.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • San Antonio, Texas, United States, 78217
        • Worldwide Clinical Trials

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and/or females 18 years to 45 years of age with a body mass index of 19 kg/m2 to 32 kg/m2 (inclusive)
  • Laboratory results (serum chemistry, hematology, and urinalysis [UA]), liver function, and serum K+ levels within normal range
  • Written informed consent
  • Female participants: Negative pregnancy test and must either be surgically sterile, postmenopausal, or agree to use acceptable nonhormonal contraception.

Exclusion Criteria:

  • All prescription or over-the-counter (OTC) medication (systemic and topical) and herbal supplements will not be permitted for 14 days before the first dose and for the duration of the study.
  • Oral, injected, or implanted hormonal contraception methods, or hormonal replacement therapy, should not have been received in the 3 months prior to the first dose, and for the duration of the study.
  • Female participants: positive pregnancy test or are breast feeding.
  • Supine systolic/diastolic blood pressure at screening, after resting for 10 min, higher than 140/90 mmHg or lower than 90/50 mmHg, confirmed after repeated testing at least approximately 1 h apart.
  • Supine pulse at screening, after resting for 10 min, outside the range of 40 to 100 beats per minute (bpm).
  • QTcF interval duration > 450 ms for male and female obtained as an average from the triplicate screening ECGs after at least 10 min in a fully supine quiet rest.
  • Abnormal waveform morphology on any of the screening ECGs that would preclude accurate measurement of the QT interval duration.
  • Family history of congenital Long QT syndrome (LQTS), a history of surviving an unexplained drowning episode, a history of any form of syncope or loss of consciousness, or known symptomatic cardiac arrhythmias.
  • Known allergy to moxifloxacin.
  • An estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) equation lower than 90 mL/min.
  • Previous participation in a CS-3150 study within 6 months prior to the single dose of CS-3150.
  • History or current evidence of clinically significant cardiac, hepatic, renal, pulmonary, endocrine, neurologic, infectious, gastrointestinal, hematologic, or oncologic disease as determined by the PI after reviewing screening history, physical examination, laboratory test results, and 12-lead ECG
  • Clinically significant illness (at the discretion of principal investigator) within 4 weeks of first dose, are carriers of Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV), or human immunodeficiency virus (HIV) antibody, and any other reason not deemed suitable for the study (at the discretion of the principal investigator).

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 10 mg CS-3150 (Treatment Sequence 1)
Participants will receive the following treatment sequence (1 treatment per Period): a single oral 10-mg dose of CS-3150, a 40-mg dose of CS-3150, a 400-mg dose of moxifloxacin, followed by placebo.
Drug: CS-3150
Single, oral administration; 10-mg or 40-mg dose
Other Names:
  • Esaxerenone
Drug: Moxifloxacin
Single, oral administration; 400 mg-tablet
Other Names:
  • Avelox
Drug: Placebo matching moxifloxacin tablet
Placebo tablets matching moxifloxacin tablets
Other Names:
  • Placebo
Experimental: 40 mg CS-3150 (Treatment Sequence 2)
Participants will receive the following treatment sequence (1 treatment per Period): a single oral 40-mg dose of CS-3150, placebo, a 10-mg dose of CS-3150, followed by a 400-mg dose of moxifloxacin.
Drug: CS-3150
Single, oral administration; 10-mg or 40-mg dose
Other Names:
  • Esaxerenone
Drug: Moxifloxacin
Single, oral administration; 400 mg-tablet
Other Names:
  • Avelox
Drug: Placebo matching moxifloxacin tablet
Placebo tablets matching moxifloxacin tablets
Other Names:
  • Placebo
Experimental: Moxifloxacin (Treatment Sequence 3)
Participants will receive the following treatment sequence (1 treatment per Period): a single oral 400-mg dose of moxifloxacin, 10-mg dose of CS-3150, placebo, 40-mg dose of CS-3150.
Drug: CS-3150
Single, oral administration; 10-mg or 40-mg dose
Other Names:
  • Esaxerenone
Drug: Moxifloxacin
Single, oral administration; 400 mg-tablet
Other Names:
  • Avelox
Drug: Placebo matching CS-3150
Placebo tablets matching CS-3150 tablets
Other Names:
  • Placebo
Experimental: Placebo (Treatment Sequence 4)
Participants will receive the following treatment sequence (1 treatment per Period): a single oral dose of placebo, 400-mg dose of moxifloxacin, 40-mg dose CS-3150, 10-mg dose of CS-3150.
Drug: CS-3150
Single, oral administration; 10-mg or 40-mg dose
Other Names:
  • Esaxerenone
Drug: Moxifloxacin
Single, oral administration; 400 mg-tablet
Other Names:
  • Avelox
Drug: Placebo matching moxifloxacin tablet
Placebo tablets matching moxifloxacin tablets
Other Names:
  • Placebo
Drug: Placebo matching CS-3150
Placebo tablets matching CS-3150 tablets
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in corrected QT (QTc) interval from baseline following oral administration of 1 of 4 treatment sequences with CS-3150
Time Frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
On the electrocardiogram tracing, the estimated difference in least square means will be reported between each CS-3150 dose level and placebo in QTc change from baseline.
Day -1 of Period 1 through Day 8 of Period 4 (~36 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of participants reporting treatment-emergent adverse events (TEAEs) following oral administration of 1 of 4 treatment sequences with CS-3150
Time Frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Change in corrected QT (QTc) interval from baseline following oral administration of 1 of 4 treatment sequences with moxifloxacin
Time Frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
On the electrocardiogram tracing, the estimated difference in least square means will be reported between moxifloxacin and placebo in QTc change from baseline.
Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Change in the interval between the P and R waves (PR) from baseline following oral administration of 1 of 4 treatment sequences with CS-3150
Time Frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
On the electrocardiogram tracing, the interval between the P and R waves (PR) at baseline and change from baseline will be summarized by treatment.
Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Change in QRS wave complex (QRS) from baseline following oral administration of 1 of 4 treatment sequences with CS-3150
Time Frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
On the electrocardiogram tracing, QRS wave complex (QRS) at baseline and change from baseline will be summarized by treatment.
Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Change in QT interval (QT) from baseline following oral administration of 1 of 4 treatment sequences with CS-3150
Time Frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
On the electrocardiogram tracing, QT interval (QT) at baseline and change from baseline will be summarized by treatment.
Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Change in QTc corrected by Bazett's formula (QTcB) from baseline following oral administration of 1 of 4 treatment sequences with CS-3150
Time Frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
On the electrocardiogram tracing, QTc corrected by Bazett's formula (QTcB) at baseline and change from baseline will be summarized by treatment.
Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Change in QTc corrected by Fridericia's formula (QTcF) from baseline following oral administration of 1 of 4 treatment sequences with CS-3150
Time Frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
On the electrocardiogram tracing, QTc corrected by Fridericia's formula ([QTcF]) at baseline and change from baseline will be summarized by treatment.
Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Change in heart rate (HR) from baseline following oral administration of 1 of 4 treatment sequences with CS-3150
Time Frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Based on the electrocardiogram tracing, heart rate (HR) at baseline and change from baseline will be summarized by treatment.
Day -1 of Period 1 through Day 8 of Period 4 (~36 days)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo, Inc.

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CS3150-A-U106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing Time Frame

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

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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