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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-183934 | Other Identifier | Japic |
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To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC-61815 16mg | Experimental | OPC-61815 16mg will be intravenously administered once a week. |
|
| OPC-61815 32mg | Experimental | OPC-61815 32mg will be intravenously administered once a week. |
|
| Moxifloxacin | Active Comparator | 400mg tablet will be administrated once a week. |
|
| Placebo | Placebo Comparator | Placebo will be intravenously administered once a week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-61815 16mg | Drug | OPC-61815 16mg will be intravenously administered once a week. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osamu Sato | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyusyu Region | Fukuoka | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 (ABDC) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of investigational medicinal product (IMP) administration in a treatment period and the next treatment period. |
| FG001 | Sequence 2 (DACB) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period. |
| FG002 | Sequence 3 (BCAD) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period. |
| FG003 | Sequence 4 (CDBA) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period. |
| FG004 | Sequence 5 (ABCD) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period. |
| FG005 | Sequence 6 (CADB) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period. |
| FG006 | Sequence 7 (BDAC) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period. |
| FG007 | Sequence 8 (DCBA) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 (ABDC) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of investigational medicinal product (IMP) administration in a treatment period and the next treatment period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | msec | Baseline, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h after dosing |
Treatment-emergent adverse events were collected from the start of IMP administration up to an average of 31 days
Safety Analysis Set included subjects who received at least 1 dose of IMP and had postdose safety data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OPC-61815 16 mg | OPC-61815 16 mg was intravenously administered once a week. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vessel puncture site pain | General disorders | MedDRA Ver. 21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2018 | Mar 11, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2018 | Mar 11, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| OPC-61815 32mg |
| Drug |
OPC-61815 32mg will be intravenously administered once a week. |
|
| Moxifloxacin | Drug | 400mg tablet will be administrated once a week. |
|
| Placebos | Drug | Placebo will be intravenously administered once a week. |
|
| BG001 | Sequence 2 (DACB) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period. |
| BG002 | Sequence 3 (BCAD) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period. |
| BG003 | Sequence 4 (CDBA) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period. |
| BG004 | Sequence 5 (ABCD) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period. |
| BG005 | Sequence 6 (CADB) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period. |
| BG006 | Sequence 7 (BDAC) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period. |
| BG007 | Sequence 8 (DCBA) | Each subject received a single dose of each of the following 4 study treatments in Periods 1 to 4 in the assigned sequence. A: OPC-6181 16 mg B: OPC-61815 32 mg C: placebo D: moxifloxacin OPC-61815 and placebo were intravenously administered in a double-blind fashion, and a moxifloxacin 400 mg tablet was orally administered with water in an open-label fashion. A washout period of at least 6 days was set between the days of IMP administration in a treatment period and the next treatment period. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
|
| 47 |
| 0 |
| 47 |
| 3 |
| 47 |
| EG001 | OPC-61815 32 mg | OPC-61815 32 mg was intravenously administered once a week. | 0 | 47 | 0 | 47 | 5 | 47 |
| EG002 | Moxifloxacin | 400 mg tablet was orally administrated once a week. | 0 | 48 | 0 | 48 | 1 | 48 |
| EG003 | Placebo | Placebo was intravenously administered once a week. | 0 | 47 | 0 | 47 | 2 | 47 |
| Folliculitis | Infections and infestations | MedDRA Ver. 21.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 21.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Ver. 21.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA Ver. 21.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Ver. 21.0 | Non-systematic Assessment |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |