A Phase 1 interventional study of CS-3150 and Moxifloxacin in Hypertension and Mineralocorticoid Receptor Antagonist, sponsored by Daiichi Sankyo. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-15.
Sponsored by Daiichi Sankyo · Phase 1, Interventional, and Prevention
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 55 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Moxifloxacin · Drug: Placebo matching moxifloxacin tablet
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 · Drug: Moxifloxacin · Drug: Placebo matching moxifloxacin tablet
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 · Drug: Moxifloxacin · Drug: Placebo matching CS-3150
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 · Drug: Moxifloxacin · Drug: Placebo matching moxifloxacin tablet · Drug: Placebo matching CS-3150
Single, oral administration; 10-mg or 40-mg dose
Also known as: Esaxerenone
Single, oral administration; 400 mg-tablet
Also known as: Avelox
Placebo tablets matching moxifloxacin tablets
Also known as: Placebo
Placebo tablets matching CS-3150 tablets
Also known as: Placebo
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.
Time frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
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
On the electrocardiogram tracing, the estimated difference in least square means will be reported between moxifloxacin and placebo in QTc change from baseline.
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
On the electrocardiogram tracing, the interval between the P and R waves (PR) at baseline and change from baseline will be summarized by treatment.
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
On the electrocardiogram tracing, QRS wave complex (QRS) at baseline and change from baseline will be summarized by treatment.
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
On the electrocardiogram tracing, QT interval (QT) at baseline and change from baseline will be summarized by treatment.
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
On the electrocardiogram tracing, QTc corrected by Bazett's formula (QTcB) at baseline and change from baseline will be summarized by treatment.
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
On the electrocardiogram tracing, QTc corrected by Fridericia's formula (\[QTcF\]) at baseline and change from baseline will be summarized by treatment.
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
Based on the electrocardiogram tracing, heart rate (HR) at baseline and change from baseline will be summarized by treatment.
Time frame: Day -1 of Period 1 through Day 8 of Period 4 (~36 days)
Plan to share: 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/
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Daiichi Sankyo