Congestive Heart FailurePhase 1NCT03510663

Phase I Study of OPC-61815

A Phase 1 study testing OPC-61815 16mg, OPC-61815 32mg and Moxifloxacin in people with Congestive Heart Failure, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male subjects Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Congestive Heart Failure
What is being tested?: OPC-61815 16mg, OPC-61815 32mg and Moxifloxacin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteJapan
Study dates: 8 May 2018to 5 Jul 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Body mass index (BMI) [body weight in kg / (height in m)2] of at least 18.5 kg/m2 and less than 25.0 kg/m2 as a result of at the screening examination
Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to start of any trial-related procedures and capable of complying with the procedures for this trial

Who cannot join

Subjects with a medical history of convulsive disorder, long QT syndrome (including family history), syncope during swimming, or any other type of syncope or cryptogenic loss of consciousness
Subjects with a serum electrolyte abnormality (hypokalemia, hypomagnesemia, hypocalcemia, etc)
Subjects with a family history of sudden death

Trial locations and contacts

1 site in 1 country.

Japan1 site

Kyusyu Region
Fukuoka

Other trials in Japan

About this study

Official title: A Single-center, Randomized, Double-blind (for OPC-61815 and Placebo), Placebo- and Moxifloxacin Positive-controlled, 4-Period Crossover Trial to Evaluate the Effect of Single Intravenous Administration of OPC-61815 at 16 and 32 mg on QT/QTc Interval in Healthy Male Subjects

To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male subjects

Conditions: Congestive Heart Failure
Being tested: OPC-61815 16mg, OPC-61815 32mg, Moxifloxacin, Placebos
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPC-61815 16mgDrug
OPC-61815 16mg will be intravenously administered once a week.
OPC-61815 32mgDrug
OPC-61815 32mg will be intravenously administered once a week.
MoxifloxacinDrug
400mg tablet will be administrated once a week.
PlacebosDrug
Placebo will be intravenously administered once a week.

Study groups in NCT03510663
Study group	Role	What they receive
OPC-61815 16mg	Experimental	OPC-61815 16mg will be intravenously administered once a week. Receives: Drug: OPC-61815 16mg
OPC-61815 32mg	Experimental	OPC-61815 32mg will be intravenously administered once a week. Receives: Drug: OPC-61815 32mg
Moxifloxacin	Active comparator	400mg tablet will be administrated once a week. Receives: Drug: Moxifloxacin
Placebo	Placebo comparator	Placebo will be intravenously administered once a week. Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG)
For each OPC-61815 dose, the upper limit of the confidence interval (CI) for the time-matched difference in the least squares (LS) mean for the change in QT corrected for heart rate by Fridericia's formula (QTcF) from baseline compared to the placebo data was evaluated to determine if it was lower than 10 msec at all postdose time points. Using a linear mixed effect model with baseline QTcF in each treatment period as a covariate, treatment, sequence, treatment period, time point, and interaction between treatment and time point as fixed effects, and subject as a random effect, point estimates and CIs for the time-matched difference in the LS mean for the change in QTcF from baseline compared to the placebo data were calculated.
Measured: Baseline, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 20185 Jul 2018

First posted27 Apr 2018
Study start8 May 2018
Primary completion5 Jul 2018
Study completion5 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03510663
Sponsor's protocol ID: 263-102-00005
Other IDs: JapicCTI-183934
Status last verified: Apr 2021
First submitted: 18 Apr 2018
Last updated: 10 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure

All Congestive Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Randomized, Double-blind (for OPC-61815 and Placebo), Placebo- and Moxifloxacin Positive-controlled, 4-Period Crossover Trial to Evaluate the Effect of Single Intravenous Administration of OPC-61815 at 16 and 32 mg on QT/QTc Interval in Healthy Male Subjects
ClinicalTrials.gov ID: NCT03510663
Acronym / sponsor ID: 263-102-00005
Conditions: Congestive Heart Failure
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 8 May 2018 (actual)
Primary completion: 5 Jul 2018 (actual)
Study completion: 5 Jul 2018 (actual)
First posted: 27 Apr 2018 (actual)
Results: Posted 10 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male subjects

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
OPC-61815 16mg	Experimental	Drug: OPC-61815 16mgOPC-61815 16mg will be intravenously administered once a week.
OPC-61815 32mg	Experimental	Drug: OPC-61815 32mgOPC-61815 32mg will be intravenously administered once a week.
Moxifloxacin	Active comparator	Drug: Moxifloxacin400mg tablet will be administrated once a week.
Placebo	Placebo comparator	Drug: PlacebosPlacebo will be intravenously administered once a week.

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Body mass index (BMI) [body weight in kg / (height in m)2] of at least 18.5 kg/m2 and less than 25.0 kg/m2 as a result of at the screening examination
Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to start of any trial-related procedures and capable of complying with the procedures for this trial

Key exclusion criteria (3 listed)

Subjects with a medical history of convulsive disorder, long QT syndrome (including family history), syncope during swimming, or any other type of syncope or cryptogenic loss of consciousness
Subjects with a serum electrolyte abnormality (hypokalemia, hypomagnesemia, hypocalcemia, etc)
Subjects with a family history of sudden death

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
OPC-61815 16mgOPC-61815 16mg will be intravenously administered once a week.	Drug	OPC-61815 16mg
OPC-61815 32mgOPC-61815 32mg will be intravenously administered once a week.	Drug	OPC-61815 32mg
Moxifloxacin400mg tablet will be administrated once a week.	Drug	Moxifloxacin
PlacebosPlacebo will be intravenously administered once a week.	Drug	Placebo

Primary outcome

Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG)
Time frame: Baseline, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h after dosing
For each OPC-61815 dose, the upper limit of the confidence interval (CI) for the time-matched difference in the least squares (LS) mean for the change in QT corrected for heart rate by Fridericia's formula (QTcF) from baseline compared to the placebo data was evaluated to determine if it was lower than 10 msec at all postdose time points. Using a linear mixed effect model with baseline QTcF in each treatment period as a covariate, treatment, sequence, treatment period, time point, and interaction between treatment and time point as fixed effects, and subject as a random effect, point estimates and CIs for the time-matched difference in the LS mean for the change in QTcF from baseline compared to the placebo data were calculated.

Results and safety

Results posted to the registry on 10 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1 (ABDC)	6	6
Sequence 2 (DACB)	6	5
Sequence 3 (BCAD)	6	6
Sequence 4 (CDBA)	6	6
Sequence 5 (ABCD)	6	6
Sequence 6 (CADB)	6	6
Sequence 7 (BDAC)	6	6
Sequence 8 (DCBA)	6	6

Primary outcome: Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG)

Time frame: Baseline, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h after dosing. Least squares mean (Standard Error). Unit: msec

Measure	OPC-61815 16 mg n = 48	OPC-61815 32 mg n = 48	Moxifloxacin n = 48	Placebo n = 48
1 hour postdose	0.9 (1.1)	0.0 (1.1)	9.9 (1.1)	-0.9 (1.1)
1.5 hours postdose	2.0 (1.1)	1.3 (1.1)	9.5 (1.1)	-0.7 (1.1)
2 hours postdose	1.7 (1.1)	0.4 (1.1)	10.8 (1.1)	-0.4 (1.1)
3 hours postdose	-1.2 (1.1)	-2.2 (1.1)	10.9 (1.1)	-0.6 (1.1)
4 hours postdose	-2.6 (1.1)	-2.2 (1.1)	11.1 (1.1)	1.5 (1.1)
6 hours postdose	-11.9 (1.1)	-10.8 (1.1)	1.9 (1.1)	-8.5 (1.1)
12 hours postdose	-9.6 (1.1)	-9.8 (1.1)	2.6 (1.1)	-4.7 (1.1)
24 hours postdose	-3.6 (1.1)	-2.8 (1.1)	4.3 (1.1)	-2.7 (1.1)

OPC-61815 16 mg vs Placebo: Least Squares Mean Difference: 1.8 (90% CI -0.4 to 4.1)
OPC-61815 16 mg vs Placebo: Least Squares Mean Difference: 2.7 (90% CI 0.4 to 4.9)
OPC-61815 16 mg vs Placebo: Least Squares Mean Difference: 2.1 (90% CI -0.1 to 4.4)

Population analysed: Central tendency analysis for OPC-61815 was performed for subjects in the Pharmacodynamic Analysis Set who appropriately completed all IMP treatments and for whom predose and postdose QT data are available for all 4 treatment periods. One subject was excluded from the central tendency analysis due to lack of QT data following OPC-61815 16 mg, OPC-61815 32 mg, and placebo administration.

Adverse events

Time frame: Treatment-emergent adverse events were collected from the start of IMP administration up to an average of 31 days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OPC-61815 16 mg	0 of 47 (0%)	3 of 47 (6.4%)	0 of 47
OPC-61815 32 mg	0 of 47 (0%)	5 of 47 (10.6%)	0 of 47
Moxifloxacin	0 of 48 (0%)	1 of 48 (2.1%)	0 of 48
Placebo	0 of 47 (0%)	2 of 47 (4.3%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Congestive Heart Failure

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure

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.

Osamu Sato study director

Otsuka Pharmaceutical Co., Ltd.

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 OPC-61815 16mg, OPC-61815 32mg and Moxifloxacin in people with Congestive Heart Failure, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

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 2 inclusion and 3 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 10 May 2021. 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 Japan. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 10 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG) (time frame: Baseline, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h after dosing). 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 NCT03510663.

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 10 May 2021.