HypertensionPhase 1NCT04019652
The Effect of CS-3150 Exposure on Corrected QT (QTc) Interval Duration in Healthy Volunteers
A Phase 1 study testing CS-3150 and Moxifloxacin in people with Hypertension and Mineralocorticoid Receptor Antagonist, run by Daiichi Sankyo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Mineralocorticoid Receptor Antagonist
- What is being tested?
- CS-3150 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2015to 23 Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- CS-3150, Moxifloxacin, Placebo matching moxifloxacin tablet, Placebo matching CS-3150
- Keywords
- Hypertension, Mineralocorticoid receptor antagonist
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS-3150Drug
Also called Esaxerenone
Single, oral administration; 10-mg or 40-mg dose
MoxifloxacinDrug
Also called Avelox
Single, oral administration; 400 mg-tablet
Placebo matching moxifloxacin tabletDrug
Also called Placebo
Placebo tablets matching moxifloxacin tablets
Placebo matching CS-3150Drug
Also called Placebo
Placebo tablets matching CS-3150 tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CS-3150; Drug: Moxifloxacin; Drug: 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. Receives: Drug: CS-3150; Drug: Moxifloxacin; Drug: 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. Receives: Drug: CS-3150; Drug: Moxifloxacin; Drug: 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. Receives: Drug: CS-3150; Drug: Moxifloxacin; Drug: Placebo matching moxifloxacin tablet; Drug: Placebo matching CS-3150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
On the electrocardiogram tracing, the estimated difference in least square means will be reported between moxifloxacin and placebo in QTc change from baseline.
Measured: 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
On the electrocardiogram tracing, the interval between the P and R waves (PR) at baseline and change from baseline will be summarized by treatment.
Measured: 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
On the electrocardiogram tracing, QRS wave complex (QRS) at baseline and change from baseline will be summarized by treatment.
Measured: 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
On the electrocardiogram tracing, QT interval (QT) at baseline and change from baseline will be summarized by treatment.
Measured: 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
On the electrocardiogram tracing, QTc corrected by Bazett's formula (QTcB) at baseline and change from baseline will be summarized by treatment.
Measured: 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
On the electrocardiogram tracing, QTc corrected by Fridericia's formula ([QTcF]) at baseline and change from baseline will be summarized by treatment.
Measured: 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
Based on the electrocardiogram tracing, heart rate (HR) at baseline and change from baseline will be summarized by treatment.
Measured: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start19 Nov 2015
- Primary completion23 Dec 2015
- Study completion23 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019652
- Sponsor's protocol ID
- CS3150-A-U106
- Status last verified
- Jul 2019
- First submitted
- 9 Jul 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Publications
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.
PubMed 32255542
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04019652
- Acronym / sponsor ID
- CS3150-A-U106
- Keywords
- Hypertension, Mineralocorticoid receptor antagonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2015 (actual)
- Primary completion
- 23 Dec 2015 (actual)
- Study completion
- 23 Dec 2015 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| 10 mg CS-3150 (Treatment Sequence 1) | Experimental | Drug: CS-3150, Drug: Moxifloxacin, Drug: Placebo matching moxifloxacin tabletParticipants 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. |
| 40 mg CS-3150 (Treatment Sequence 2) | Experimental | Drug: CS-3150, Drug: Moxifloxacin, Drug: Placebo matching moxifloxacin tabletParticipants 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. |
| Moxifloxacin (Treatment Sequence 3) | Experimental | Drug: CS-3150, Drug: Moxifloxacin, Drug: Placebo matching CS-3150Participants 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. |
| Placebo (Treatment Sequence 4) | Experimental | Drug: CS-3150, Drug: Moxifloxacin, Drug: Placebo matching moxifloxacin tablet, Drug: Placebo matching CS-3150Participants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CS-3150Also: EsaxerenoneSingle, oral administration; 10-mg or 40-mg dose | Drug | 10 mg CS-3150 (Treatment Sequence 1), 40 mg CS-3150 (Treatment Sequence 2), Moxifloxacin (Treatment Sequence 3), Placebo (Treatment Sequence 4) |
| MoxifloxacinAlso: AveloxSingle, oral administration; 400 mg-tablet | Drug | 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 tabletAlso: PlaceboPlacebo tablets matching moxifloxacin tablets | Drug | 10 mg CS-3150 (Treatment Sequence 1), 40 mg CS-3150 (Treatment Sequence 2), Placebo (Treatment Sequence 4) |
| Placebo matching CS-3150Also: PlaceboPlacebo tablets matching CS-3150 tablets | Drug | Moxifloxacin (Treatment Sequence 3), Placebo (Treatment Sequence 4) |
Primary outcome
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.
8 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Derived from this study: PubMed 32255542Mendell 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.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Leader study director
Daiichi Sankyo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CS-3150 and Moxifloxacin in people with Hypertension and Mineralocorticoid Receptor Antagonist, run by Daiichi Sankyo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04019652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.