NCT04019652

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1 hypertension

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 19, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2015

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

1 month

First QC Date

July 9, 2019

Last Update Submit

July 12, 2019

Conditions

HypertensionMineralocorticoid Receptor Antagonist

Keywords

HypertensionMineralocorticoid receptor antagonist

Outcome Measures

Primary Outcomes (1)

  • Change in corrected QT (QTc) interval from baseline following oral administration of 1 of 4 treatment sequences with CS-3150

    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 Outcomes (8)

  • Percentage of participants reporting treatment-emergent adverse events (TEAEs) following oral administration of 1 of 4 treatment sequences with CS-3150

    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

    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

    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

    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

    Day -1 of Period 1 through Day 8 of Period 4 (~36 days)

  • +3 more secondary outcomes

Study Arms (4)

10 mg CS-3150 (Treatment Sequence 1)

EXPERIMENTAL

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-3150Drug: MoxifloxacinDrug: Placebo matching moxifloxacin tablet

40 mg CS-3150 (Treatment Sequence 2)

EXPERIMENTAL

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-3150Drug: MoxifloxacinDrug: Placebo matching moxifloxacin tablet

Moxifloxacin (Treatment Sequence 3)

EXPERIMENTAL

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-3150Drug: MoxifloxacinDrug: Placebo matching CS-3150

Placebo (Treatment Sequence 4)

EXPERIMENTAL

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-3150Drug: MoxifloxacinDrug: Placebo matching moxifloxacin tabletDrug: Placebo matching CS-3150

Interventions

CS-3150DRUG

Single, oral administration; 10-mg or 40-mg dose

Also known as: Esaxerenone
10 mg CS-3150 (Treatment Sequence 1)40 mg CS-3150 (Treatment Sequence 2)Moxifloxacin (Treatment Sequence 3)Placebo (Treatment Sequence 4)
MoxifloxacinDRUG

Single, oral administration; 400 mg-tablet

Also known as: Avelox
10 mg CS-3150 (Treatment Sequence 1)40 mg CS-3150 (Treatment Sequence 2)Moxifloxacin (Treatment Sequence 3)Placebo (Treatment Sequence 4)
Placebo matching moxifloxacin tabletDRUG

Placebo tablets matching moxifloxacin tablets

Also known as: Placebo
10 mg CS-3150 (Treatment Sequence 1)40 mg CS-3150 (Treatment Sequence 2)Placebo (Treatment Sequence 4)
Placebo matching CS-3150DRUG

Placebo tablets matching CS-3150 tablets

Also known as: Placebo
Moxifloxacin (Treatment Sequence 3)Placebo (Treatment Sequence 4)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

Related Publications (1)

  • Mendell J, Kobayashi F, Shimizu T. Randomized, Double-Blind, Single-Dose, Placebo-Controlled Crossover Study to Evaluate the Effects of Esaxerenone on QTc Interval in Healthy Subjects. Clin Pharmacol Drug Dev. 2020 Aug;9(6):709-718. doi: 10.1002/cpdd.794. Epub 2020 Apr 7.

    PMID: 32255542DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

esaxerenoneMoxifloxacin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Clinical Study Leader

    Daiichi Sankyo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The Investigator, participants, and all other clinical management and personnel will be blinded to treatment. CS-3150 and moxifloxacin (positive control) treatments will be blinded by matching placebos.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: This is a phase 1, single center, randomized, single-dose, double-blind, double-dummy, placebo- and positive-controlled, 4-period crossover study. Participants will be randomized to one of the following 4 treatment sequences: 1. CS-3150 (10-mg dose)/CS-3150 (40-mg dose)/moxifloxacin/placebo 2. CS-3150 (40-mg dose)/placebo/CS-3150 (10-mg dose)/moxifloxacin 3. Moxifloxacin/CS-3150 (10-mg dose)/placebo/CS-3150 (40-mg dose) 4. Placebo/moxifloxacin/CS-3150 (40-mg dose)/CS-3150 (10-mg dose)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 15, 2019

Study Start

November 19, 2015

Primary Completion

December 23, 2015

Study Completion

December 23, 2015

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

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/

Shared Documents
STUDY PROTOCOL, SAP, CSR
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.
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.
More information

Locations

US(1)