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| ID | Type | Description | Link |
|---|---|---|---|
| 263791 | Other Identifier | Paraxel |
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This was a double-blind, randomized, placebo- and positive-controlled, parallel group, 3-arm study that assessed the potential for therapeutic and supratherapeutic concentrations of setmelanotide to affect the QTc corrected by the Fredericia method (QTcF) interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Setmelanotide 2-7 mg + Placebo for Moxifloxacin | Experimental | Participants received titrated doses of 2-7 milligrams (mg) setmelanotide once daily by subcutaneous (SC) injection, starting with a dose of 2 mg from Days 1 to 7, 3 mg from Days 8 to 10, 5 mg from Days 11 to 13 and 7 mg from Days 14 to 16. Participants also received single oral dose of placebo matching moxifloxacin on Days 10 and 16. |
|
| Group 2: Placebo for Setmelanotide + Moxifloxacin 400 mg + Placebo for Moxifloxacin | Active Comparator | Participants received placebo matching setmelanotide once daily by SC injection from Days 1 to 16. Participants also received a single oral dose of 400 mg moxifloxacin on Day 10 and a single oral dose of placebo matching moxifloxacin on Day 16. |
|
| Group 3: Placebo for Setmelanotide + Placebo for Moxifloxacin + Moxifloxacin 400 mg | Active Comparator | Participants received placebo matching setmelanotide once daily by SC injection from Days 1 to 16. Participants also received a single oral dose of placebo matching moxifloxacin on Day 10 and a single oral dose of 400 mg moxifloxacin on Day 16. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Setmelanotide | Drug | Administered once daily via SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 | Continuous 12-lead digital electrocardiogram (ECG) recording was performed on Baseline and Day 10. ECG analysts were blinded to the treatment, timepoint and participant. QT interval was corrected for heart rate using QTcF. CHFB in QTcF was calculated at each timepoint. | Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hours (hrs) postdose |
| Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 | Continuous 12-lead digital ECG recording was performed on Baseline and Day 16. ECG analysts were blinded to the treatment, timepoint and participant. QT interval was corrected for heart rate using QTcF. CHFB in QTcF was calculated at each timepoint. | Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 | The CHFB in HR was analyzed using an analysis of variance model (ANOVA) including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. Placebo corrected values were reported in the inferential statistics. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Meeker, MD | Rhythm Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel Early Phase Clinical Unit (Los Angeles) | Glendale | California | 91206 | United States |
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Participants were randomized 1:1:1 into Group 1, 2, or 3.
77 healthy participants aged 18 to 50 years, inclusive, were enrolled in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Setmelanotide 2-7 mg + Placebo for Moxifloxacin | Participants received titrated doses of 2-7 milligrams (mg) setmelanotide once daily by subcutaneous (SC) injection, starting with a dose of 2 mg from Days 1 to 7, 3 mg from Days 8 to 10, 5 mg from Days 11 to 13 and 7 mg from Days 14 to 16. Participants also received single oral dose of placebo matching moxifloxacin on Days 10 and 16. |
| FG001 | Group 2: Placebo for Setmelanotide + Moxifloxacin 400 mg + Placebo for Moxifloxacin | Participants received placebo matching setmelanotide once daily by SC injection from Days 1 to 16. Participants also received a single oral dose of 400 mg moxifloxacin on Day 10 and a single oral dose of placebo matching moxifloxacin on Day 16. |
| FG002 | Group 3: Placebo for Setmelanotide + Placebo for Moxifloxacin + Moxifloxacin 400 mg | Participants received placebo matching setmelanotide once daily by SC injection from Days 1 to 16. Participants also received a single oral dose of placebo matching moxifloxacin on Day 10 and a single oral dose of 400 mg moxifloxacin on Day 16 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety population included all participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Setmelanotide 2-7 mg + Placebo for Moxifloxacin | Participants received titrated doses of 2-7 mg setmelanotide once daily by SC injection, starting with a dose of 2 mg from Days 1 to 7, 3 mg from Days 8 to 10, 5 mg from Days 11 to 13 and 7 mg from Days 14 to 16. Participants also received single oral dose of placebo matching moxifloxacin on Days 10 and 16. |
| 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 | Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10 | Continuous 12-lead digital electrocardiogram (ECG) recording was performed on Baseline and Day 10. ECG analysts were blinded to the treatment, timepoint and participant. QT interval was corrected for heart rate using QTcF. CHFB in QTcF was calculated at each timepoint. | Pharmacokinetic (PK)/QTc Population included participants who were in both ECG & PK populations. PK Population included all participants who received at least 1 dose of setmelanotide or moxifloxacin & have at least 1 quantifiable concentration of setmelanotide or moxifloxacin. ECG Population included all participants in safety population with measurements at baseline as well as on-treatment with at least one post-dose timepoint with a valid value. Participants with available data were reported. | Posted | Mean | Standard Deviation | milliseconds (msec) | Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hours (hrs) postdose |
|
From first dose up to Day 23
The Safety population included all participants who received at least one dose of study drug.
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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 | Group 1: Setmelanotide 2 mg | Participants received once daily setmelanotide 2 mg from Days 1 to 7, via SC injection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rhythm Clinical Trials | Rhythm Pharmaceuticals, Inc. | 857-264-4280 | clinicaltrials@rhythmtx.com |
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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 | Nov 24, 2021 | Sep 7, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2022 | Apr 3, 2024 | SAP_002.pdf |
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| ID | Term |
|---|---|
| C579663 | setmelanotide |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin | Drug | Moxifloxacin capsules via oral administration. |
|
| Oral Placebo | Drug | Placebo capsules via oral administration. |
|
| SC Placebo | Drug | Placebo via SC injection. |
|
| Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hours (hrs) postdose |
| Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 | The CHFB in HR was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. | Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
| Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 | The CHFB in QTcF was analyzed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. | Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
| Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 | The CHFB in QTcF was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. | Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
| Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 | The CHFB in PR was analyzed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. | Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
| Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 | The CHFB in PR was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. | Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
| Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 | The CHFB in QRS was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. | Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
| Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 | The CHFB in QRS was analyzed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. | Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
| Number of Participants With at Least One Treatment-Emergent Abnormal Value in HR Intervals After Administration of SC Setmelanotide | A treatment-emergent abnormality/finding was defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included: HR (<40 beats/min, HR>120 beats/min and Relative CHFB >25%) Relative CHFB = 100*(Value-Baseline)/Baseline | Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg) |
| Number of Participants With at Least One Treatment-Emergent Abnormal Value in PR Intervals After Administration of SC Setmelanotide | A treatment-emergent abnormality/finding was defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included: PR (>220 msec, Relative CHFB >25%); Relative CHFB = 100*(Value-Baseline)/Baseline | Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg) |
| Number of Participants With at Least One Treatment-Emergent Abnormal Value in QRS Intervals After Administration of SC Setmelanotide | A treatment-emergent abnormality/finding was defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included: QRS ( >120 msec, Relative CHFB >25%); Relative CHFB = 100*(Value-Baseline)/Baseline | Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg) |
| Number of Participants With at Least One Treatment-Emergent Abnormal Value in QTcF Intervals After Administration of SC Setmelanotide | A treatment-emergent abnormality/finding was defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included: QTcF (450<QTc<=480 msec, 480<QTc<=500 msec, QTc>500 msec, 30<CHFB in QTc<=60 msec, CHFB in >60 msec) | Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg) |
| Number of Participants With at Least One Treatment-Emergent Abnormal Finding in T-wave Morphology and U-wave Presence After Administration of SC Setmelanotide | A treatment-emergent abnormality/finding will be defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included : QTcF Increase From Baseline, > 30 msec And < 60 msec | Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg) |
| Moxifloxacin Concentration-related CHFB in QTcF at Day 10 | Continuous 12-lead digital ECG recording was performed on Baseline and Day 10. ECG analysts were blinded to the treatment, timepoint and participant. CHFB in QTcF was calculated at each timepoint. | Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
| Moxifloxacin Concentration-related CHFB in QTcF at Day 16 | Continuous 12-lead digital ECG recording was performed on Baseline and Day 16. ECG analysts were blinded to the treatment, timepoint and participant. CHFB in QTcF was calculated at each timepoint. | Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
| Positive Covid19 Result. |
|
| BG001 |
| Group 2: Placebo for Setmelanotide + Moxifloxacin 400 mg + Placebo for Moxifloxacin |
Participants received placebo matching setmelanotide once daily by SC injection from Days 1 to 16. Participants also received a single oral dose of 400 mg moxifloxacin on Day 10 and a single oral dose of placebo matching moxifloxacin on Day 16. |
| BG002 | Group 3: Placebo for Setmelanotide + Placebo for Moxifloxacin + Moxifloxacin 400 mg | Participants received placebo matching setmelanotide once daily by SC injection from Days 1 to 16. Participants also received a single oral dose of placebo matching moxifloxacin on Day 10 and a single oral dose of 400 mg moxifloxacin on Day 16. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 |
| Group 1: Setmelanotide 3 mg |
Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection. |
| OG001 | Group 3: Placebo | Participants received once daily placebo from Days 8 to 10, via SC injection. |
|
|
|
| Primary | Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16 | Continuous 12-lead digital ECG recording was performed on Baseline and Day 16. ECG analysts were blinded to the treatment, timepoint and participant. QT interval was corrected for heart rate using QTcF. CHFB in QTcF was calculated at each timepoint. | PK/QTc Population included participants who were in both ECG & PK populations. PK Population included all participants who received at least 1 dose of setmelanotide or moxifloxacin and have at least one quantifiable concentration of setmelanotide or moxifloxacin. ECG Population included all participants in safety population with measurements at baseline as well as on-treatment with at least one post-dose timepoint with a valid value. Participants with available data were reported. | Posted | Mean | Standard Deviation | msec | Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
|
|
|
|
| Secondary | Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 | The CHFB in HR was analyzed using an analysis of variance model (ANOVA) including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. Placebo corrected values were reported in the inferential statistics. | ECG population with available data was analyzed. ECG data was collected on Day 10 where participants received setmelanotide 3 mg. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hours (hrs) postdose |
|
|
|
|
| Secondary | Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 | The CHFB in HR was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. | ECG population with available data was analyzed. ECG data was collected on Day 16, where participants received setmelanotide 7 mg. | Posted | Mean | Standard Deviation | bpm | Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
|
|
|
|
| Secondary | Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 | The CHFB in QTcF was analyzed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. | ECG population with available data was analyzed. ECG data was collected on Day 10, where participants received setmelanotide 3 mg. | Posted | Mean | Standard Deviation | msec | Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
|
|
|
|
| Secondary | Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 | The CHFB in QTcF was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. | ECG population with available data was analyzed. ECG data was collected on Day 16, where participants received setmelanotide 7 mg. | Posted | Mean | Standard Deviation | msec | Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
|
|
|
|
| Secondary | Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 | The CHFB in PR was analyzed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. | ECG population with available data was analyzed. ECG data was collected on Day 10, where participants received setmelanotide 3 mg. | Posted | Mean | Standard Deviation | msec | Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
|
|
|
|
| Secondary | Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 | The CHFB in PR was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. | ECG population with available data was analyzed. ECG data was collected on Day 16, where participants received setmelanotide 7 mg. | Posted | Mean | Standard Deviation | msec | Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
|
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|
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| Secondary | Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10 | The CHFB in QRS was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. | ECG population with available data was analyzed. ECG data was collected on Day 10, where participants received setmelanotide 3 mg. | Posted | Mean | Standard Deviation | msec | Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
|
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|
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| Secondary | Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16 | The CHFB in QRS was analyzed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. | ECG population with available data was analyzed. ECG data was collected on Day 16, where participants received setmelanotide 7 mg. | Posted | Mean | Standard Deviation | msec | Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
|
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|
|
| Secondary | Number of Participants With at Least One Treatment-Emergent Abnormal Value in HR Intervals After Administration of SC Setmelanotide | A treatment-emergent abnormality/finding was defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included: HR (<40 beats/min, HR>120 beats/min and Relative CHFB >25%) Relative CHFB = 100*(Value-Baseline)/Baseline | ECG population with available data was analyzed. ECG data was collected on Days 10 and 16, where participants received setmelanotide 3 mg and 7 mg respectively. | Posted | Count of Participants | Participants | Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg) |
|
|
|
| Secondary | Number of Participants With at Least One Treatment-Emergent Abnormal Value in PR Intervals After Administration of SC Setmelanotide | A treatment-emergent abnormality/finding was defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included: PR (>220 msec, Relative CHFB >25%); Relative CHFB = 100*(Value-Baseline)/Baseline | ECG Population with available data was analyzed. ECG data was collected on Days 10 and 16, where participants received setmelanotide 3 mg and 7 mg respectively. | Posted | Count of Participants | Participants | Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg) |
|
|
|
| Secondary | Number of Participants With at Least One Treatment-Emergent Abnormal Value in QRS Intervals After Administration of SC Setmelanotide | A treatment-emergent abnormality/finding was defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included: QRS ( >120 msec, Relative CHFB >25%); Relative CHFB = 100*(Value-Baseline)/Baseline | ECG Population with available data was analyzed. ECG data was collected on Days 10 and 16, where participants received setmelanotide 3 mg and 7 mg respectively. | Posted | Count of Participants | Participants | Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg) |
|
|
|
| Secondary | Number of Participants With at Least One Treatment-Emergent Abnormal Value in QTcF Intervals After Administration of SC Setmelanotide | A treatment-emergent abnormality/finding was defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included: QTcF (450<QTc<=480 msec, 480<QTc<=500 msec, QTc>500 msec, 30<CHFB in QTc<=60 msec, CHFB in >60 msec) | ECG Population with available data was analyzed. ECG data was collected on Days 10 and 16, where participants received setmelanotide 3 mg and 7 mg respectively. | Posted | Count of Participants | Participants | Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg) |
|
|
|
| Secondary | Number of Participants With at Least One Treatment-Emergent Abnormal Finding in T-wave Morphology and U-wave Presence After Administration of SC Setmelanotide | A treatment-emergent abnormality/finding will be defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included : QTcF Increase From Baseline, > 30 msec And < 60 msec | ECG population with available data was analyzed. ECG data was collected on Days 10 and 16, where participants received setmelanotide 3 mg and 7 mg respectively. | Posted | Count of Participants | Participants | Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg) |
|
|
|
| Secondary | Moxifloxacin Concentration-related CHFB in QTcF at Day 10 | Continuous 12-lead digital ECG recording was performed on Baseline and Day 10. ECG analysts were blinded to the treatment, timepoint and participant. CHFB in QTcF was calculated at each timepoint. | PK/QTc Population was analyzed. Participants with available data were reported. | Posted | Mean | Standard Deviation | msec | Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
|
|
|
| Secondary | Moxifloxacin Concentration-related CHFB in QTcF at Day 16 | Continuous 12-lead digital ECG recording was performed on Baseline and Day 16. ECG analysts were blinded to the treatment, timepoint and participant. CHFB in QTcF was calculated at each timepoint. | PK/QTc Population was analyzed. Participants with available data were reported. | Posted | Mean | Standard Deviation | msec | Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose |
|
|
|
| 0 |
| 28 |
| 1 |
| 28 |
| 25 |
| 28 |
| EG001 | Group 1: Setmelanotide 3 mg | Participants received once daily setmelanotide 3 mg from Days 8 to 10, via SC injection. | 0 | 24 | 0 | 24 | 16 | 24 |
| EG002 | Group 1: Setmelanotide 5 mg | Participants received once daily setmelanotide 5 mg from Days 11 to 13, via SC injection. | 0 | 23 | 0 | 23 | 17 | 23 |
| EG003 | Group 1: Setmelanotide 7 mg | Participants received once daily setmelanotide 7 mg from Days 14 to 16, via SC injection. | 0 | 21 | 0 | 21 | 9 | 21 |
| EG004 | Group 2: Placebo | Participants received once daily Placebo from Days 1 to 16, via SC injection and orally on Day 16. | 0 | 24 | 0 | 24 | 18 | 24 |
| EG005 | Group 2: Moxifloxacin 400mg | Participants received a single oral dose of 400 mg moxifloxacin on Day 10. | 0 | 23 | 0 | 23 | 17 | 23 |
| EG006 | Group 3: Placebo | Participants received once daily Placebo from Days 1 to 16, via SC injection and orally on Day 10. | 0 | 25 | 0 | 25 | 15 | 25 |
| EG007 | Group 3: Moxifloxacin 400mg | Participants received a single oral dose of 400 mg moxifloxacin on Day 16. | 0 | 25 | 0 | 25 | 4 | 25 |
| Hepatitis acute | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Medical device site dermatitis | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Injection site bruising | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Injection site discolouration | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Change of bowel habit | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Chapped lips | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Gingival discolouration | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Hyperaesthesia teeth | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Lip discolouration | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Lip dry | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Pigmentation lip | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Tongue pigmentation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Ephelides | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Skin mass | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Skin odour abnormal | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Allodynia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Erection increased | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Disturbance in sexual arousal | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
All information regarding setmelanotide supplied by Rhythm to the investigator is privileged and confidential information. The investigator agrees to use this information to accomplish the study and will not use it for other purposes without consent from Rhythm. The information obtained from the clinical study will be used towards the development of setmelanotide and may be disclosed to regulatory authority(ies), other investigators, corporate partners, or consultants as required.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 0.5 hr Post dose |
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| 1 hr Post dose |
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| 1.5 hr Post dose |
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| 2 hr Post dose |
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| 2.5 hr Post dose |
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| 3 hr Post dose |
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| 4 hr Post dose |
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| 5 hr Post dose |
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| 6 hr Post dose |
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| 7 hr Post dose |
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| 8 hr Post dose |
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| 9 hr Post dose |
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| 10 hr Post dose |
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| 12 hr Post dose |
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| 16 hr Post dose |
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| 24 hr Post dose |
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| 0.5 hr Post dose |
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| 1 hr Post dose |
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| 1.5 hr Post dose |
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| 2 hr Post dose |
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| 2.5 hr Post dose |
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| 3 hr Post dose |
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| 4 hr Post dose |
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| 5 hr Post dose |
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| 6 hr Post dose |
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| 7 hr Post dose |
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| 8 hr Post dose |
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| 9 hr Post dose |
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| 10 hr Post dose |
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| 12 hr Post dose |
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| 16 hr Post dose |
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| 24 hr Post dose |
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| LS Mean |
| 0.1 |
| 2-Sided |
| 90 |
| -3.0 |
| 3.1 |
| Other |
| 1 hr Post dose | LS Mean | 0.1 | 2-Sided | 90 | -2.8 | 3.0 | Other |
| 1.5 hr Post dose | LS Mean | 1.6 | 2-Sided | 90 | -1.8 | 5.1 | Other |
| 2 hr Post dose | LS Mean | 0.7 | 2-Sided | 90 | -2.8 | 4.1 | Other |
| 2.5 hr Post dose | LS Mean | 0.2 | 2-Sided | 90 | -2.9 | 3.4 | Other |
| 3 hr Post dose | LS Mean | 2.2 | 2-Sided | 90 | -1.4 | 5.7 | Other |
| 4 hr Post dose | LS Mean | -0.1 | 2-Sided | 90 | -2.9 | 2.7 | Other |
| 5 hr Post dose | LS Mean | -0.2 | 2-Sided | 90 | -3.1 | 2.7 | Other |
| 6 hr Post dose | LS Mean | -0.8 | 2-Sided | 90 | -3.8 | 2.3 | Other |
| 7 hr Post dose | LS Mean | -2.8 | 2-Sided | 90 | -5.5 | -0.1 | Other |
| 8 hr Post dose | LS Mean | -1.6 | 2-Sided | 90 | -4.5 | 1.3 | Other |
| 9 hr Post dose | LS Mean | 0.3 | 2-Sided | 90 | -2.5 | 3.0 | Other |
| 10 hr Post dose | LS Mean | 0.2 | 2-Sided | 90 | -2.3 | 2.7 | Other |
| 12 hr Post dose | LS Mean | -3.0 | 2-Sided | 90 | -5.9 | -0.1 | Other |
| 16 hr Post dose | LS Mean | -2.0 | 2-Sided | 90 | -5.1 | 1.0 | Other |
| 24 hr Post dose | LS Mean | 1.1 | 2-Sided | 90 | -1.6 | 3.8 | Other |
| Pre-dose | LS Mean | 1.4 | 2-Sided | 90 | -1.7 | 4.5 | Other |
| 0.5 hr Post dose | LS Mean | 1.7 | 2-Sided | 90 | -1.4 | 4.7 | Other |
| 1 hr Post dose | LS Mean | 1.9 | 2-Sided | 90 | -1.0 | 4.8 | Other |
| 1.5 hr Post dose | LS Mean | 2.6 | 2-Sided | 90 | -0.9 | 6.0 | Other |
| 2 hr Post dose | LS Mean | 1.3 | 2-Sided | 90 | -2.1 | 4.8 | Other |
| 2.5 hr Post dose | LS Mean | 1.7 | 2-Sided | 90 | -1.4 | 4.9 | Other |
| 3 hr Post dose | LS Mean | 1.6 | 2-Sided | 90 | -1.9 | 5.1 | Other |
| 4 hr Post dose | LS Mean | 1.4 | 2-Sided | 90 | -1.4 | 4.2 | Other |
| 5 hr Post dose | LS Mean | 2.7 | 2-Sided | 90 | -0.2 | 5.7 | Other |
| 6 hr Post dose | LS Mean | 4.4 | 2-Sided | 90 | 1.4 | 7.5 | Other |
| 7 hr Post dose | LS Mean | 2.8 | 2-Sided | 90 | 0.1 | 5.5 | Other |
| 8 hr Post dose | LS Mean | 4.1 | 2-Sided | 90 | 1.2 | 7.0 | Other |
| 9 hr Post dose | LS Mean | 3.6 | 2-Sided | 90 | 0.8 | 6.3 | Other |
| 10 hr Post dose | LS Mean | 3.3 | 2-Sided | 90 | 0.8 | 5.8 | Other |
| 12 hr Post dose | LS Mean | 2.6 | 2-Sided | 90 | -0.3 | 5.5 | Other |
| 16 hr Post dose | LS Mean | 0.3 | 2-Sided | 90 | -2.7 | 3.4 | Other |
| 24 hr Post dose | LS Mean | 1.7 | 2-Sided | 90 | -1.0 | 4.4 | Other |
| 0.5 hr Post dose |
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| 1 hr Post dose |
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| 1.5 hr Post dose |
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| 2 hr Post dose |
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| 2.5 hr Post dose |
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| 3 hr Post dose |
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| 4 hr Post dose |
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| 5 hr Post dose |
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| 6 hr Post dose |
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| 7 hr Post dose |
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| 8 hr Post dose |
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| 9 hr Post dose |
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| 10 hr Post dose |
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| 12 hr Post dose |
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| 16 hr Post dose |
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| 24 hr Post dose |
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| LS Mean |
| -2.1 |
| 2-Sided |
| 90 |
| -5.3 |
| 1.0 |
| Other |
| 1 hr Post dose | LS Mean | -1.6 | 2-Sided | 90 | -4.7 | 1.4 | Other |
| 1.5 hr Post dose | LS Mean | -2.2 | 2-Sided | 90 | -5.3 | 1.0 | Other |
| 2 hr Post dose | LS Mean | -3.3 | 2-Sided | 90 | -6.3 | -0.3 | Other |
| 2.5 hr Post dose | LS Mean | -1.2 | 2-Sided | 90 | -4.1 | 1.7 | Other |
| 3 hr Post dose | LS Mean | -1.3 | 2-Sided | 90 | -4.2 | 1.7 | Other |
| 4 hr Post dose | LS Mean | -0.6 | 2-Sided | 90 | -3.6 | 2.5 | Other |
| 5 hr Post dose | LS Mean | -1.0 | 2-Sided | 95 | -4.1 | 2.1 | Other |
| 6 hr Post dose | LS Mean | 0.4 | 2-Sided | 90 | -2.7 | 3.5 | Other |
| 7 hr Post dose | LS Mean | -2.5 | 2-Sided | 90 | -5.5 | 0.5 | Other |
| 8 hr Post dose | LS Mean | -2.2 | 2-Sided | 90 | -5.2 | 0.8 | Other |
| 9 hr Post dose | LS Mean | -0.9 | 2-Sided | 90 | -4.3 | 2.6 | Other |
| 10 hr Post dose | LS Mean | -0.2 | 2-Sided | 90 | -3.6 | 3.2 | Other |
| 12 hr Post dose | LS Mean | -2.2 | 2-Sided | 90 | -5.5 | 1.0 | Other |
| 16 hr Post dose | LS Mean | -1.9 | 2-Sided | 90 | -5.4 | 1.7 | Other |
| 24 hr Post dose | LS Mean | 2.6 | 2-Sided | 90 | -1.2 | 6.3 | Other |
| Pre-dose | LS Mean | -2.1 | 2-Sided | 90 | -5.1 | 0.8 | Other |
| 0.5 hr Post dose | LS Mean | -0.1 | 2-Sided | 90 | -3.1 | 3.0 | Other |
| 1 hr Post dose | LS Mean | -0.1 | 2-Sided | 90 | -3.0 | 2.9 | Other |
| 1.5 hr Post dose | LS Mean | -0.1 | 2-Sided | 90 | -3.1 | 3.0 | Other |
| 2 hr Post dose | LS Mean | -0.9 | 2-Sided | 90 | -3.8 | 2.0 | Other |
| 2.5 hr Post dose | LS Mean | 0.2 | 2-Sided | 90 | -2.5 | 3.0 | Other |
| 3 hr Post dose | LS Mean | 0.9 | 2-Sided | 90 | -1.9 | 3.7 | Other |
| 4 hr Post dose | LS Mean | 0.7 | 2-Sided | 90 | -2.2 | 3.7 | Other |
| 5 hr Post dose | LS Mean | 0.1 | 2-Sided | 90 | -2.8 | 3.1 | Other |
| 6 hr Post dose | LS Mean | -0.9 | 2-Sided | 90 | -3.9 | 2.0 | Other |
| 7 hr Post dose | LS Mean | -0.2 | 2-Sided | 90 | -3.1 | 2.7 | Other |
| 8 hr Post dose | LS Mean | 0.2 | 2-Sided | 90 | -2.7 | 3.1 | Other |
| 9 hr Post dose | LS Mean | 0.7 | 2-Sided | 90 | -2.7 | 4.0 | Other |
| 10 hr Post dose | LS Mean | 0.9 | 2-Sided | 90 | -2.3 | 4.1 | Other |
| 12 hr Post dose | LS Mean | -0.4 | 2-Sided | 90 | -3.5 | 2.8 | Other |
| 16 hr Post dose | LS Mean | -0.4 | 2-Sided | 90 | -3.8 | 3.0 | Other |
| 24 hr Post dose | LS Mean | -1.6 | 2-Sided | 90 | -5.1 | 2.0 | Other |
| 0.5 hr Post dose |
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| 1 hr Post dose |
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| 1.5 hr Post dose |
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| 2 hr Post dose |
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| 2.5 hr Post dose |
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| 3 hr Post dose |
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| 4 hr Post dose |
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| 5 hr Post dose |
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| 6 hr Post dose |
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| 7 hr Post dose |
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| 8 hr Post dose |
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| 9 hr Post dose |
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| 10 hr Post dose |
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| 12 hr Post dose |
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| 16 hr Post dose |
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| 24 hr Post dose |
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| LS Mean |
| 0.8 |
| 2-Sided |
| 90 |
| -3.0 |
| 4.6 |
| Other |
| 1 hr Post dose | LS Mean | -0.1 | 2-Sided | 90 | -4.1 | 3.9 | Other |
| 1.5 hr Post dose | LS Mean | 0.9 | 2-Sided | 90 | -2.7 | 4.4 | Other |
| 2 hr Post dose | LS Mean | 3.0 | 2-Sided | 90 | -0.6 | 6.6 | Other |
| 2.5 hr Post dose | LS Mean | 3.5 | 2-Sided | 90 | -0.3 | 7.4 | Other |
| 3 hr Post dose | LS Mean | 4.6 | 2-Sided | 90 | 1.2 | 8.1 | Other |
| 4 hr Post dose | LS Mean | 5.2 | 2-Sided | 90 | 1.5 | 8.9 | Other |
| 5 hr Post dose | LS Mean | 2.0 | 2-Sided | 90 | -1.7 | 5.8 | Other |
| 6 hr Post dose | LS Mean | 1.7 | 2-Sided | 90 | -1.6 | 5.1 | Other |
| 7 hr Post dose | LS Mean | 2.3 | 2-Sided | 90 | -1.1 | 5.7 | Other |
| 8 hr Post dose | LS Mean | 2.4 | 2-Sided | 90 | -1.4 | 6.2 | Other |
| 9 hr Post dose | LS Mean | 4.4 | 2-Sided | 90 | 0.9 | 7.8 | Other |
| 10 hr Post dose | LS Mean | 3.8 | 2-Sided | 90 | 0.3 | 7.4 | Other |
| 12 hr Post dose | LS Mean | -0.8 | 2-Sided | 90 | -4.2 | 2.7 | Other |
| 16 hr Post dose | LS Mean | 3.6 | 2-Sided | 90 | 0.1 | 7.0 | Other |
| 24 hr Post dose | LS Mean | -1.5 | 2-Sided | 90 | -5.7 | 2.8 | Other |
| Pre dose | LS Mean | 2.3 | 2-Sided | 90 | -1.0 | 5.6 | Other |
| 0.5 hr Post dose | LS Mean | -1.6 | 2-Sided | 90 | -5.4 | 2.2 | Other |
| 1 hr Post dose | LS Mean | 0.3 | 2-Sided | 90 | -3.8 | 4.3 | Other |
| 1.5 hr Post dose | LS Mean | 4.0 | 2-Sided | 90 | 0.4 | 7.6 | Other |
| 2 hr Post dose | LS Mean | 6.3 | 2-Sided | 90 | 2.7 | 10.0 | Other |
| 2.5 hr Post dose | LS Mean | 6.4 | 2-Sided | 90 | 2.6 | 10.2 | Other |
| 3 hr Post dose | LS Mean | 8.5 | 2-Sided | 90 | 5.0 | 12.0 | Other |
| 4 hr Post dose | LS Mean | 10.1 | 2-Sided | 90 | 6.4 | 13.8 | Other |
| 5 hr Post dose | LS Mean | 7.8 | 2-Sided | 90 | 4.1 | 11.6 | Other |
| 6 hr Post dose | LS Mean | 7.8 | 2-Sided | 90 | 4.4 | 11.2 | Other |
| 7 hr Post dose | LS Mean | 6.8 | 2-Sided | 90 | 3.4 | 10.2 | Other |
| 8 hr Post dose | LS Mean | 4.5 | 2-Sided | 90 | 0.6 | 8.3 | Other |
| 9 hr Post dose | LS Mean | 6.5 | 2-Sided | 90 | 3.1 | 10.0 | Other |
| 10 hr Post dose | LS Mean | 6.6 | 2-Sided | 90 | 3.0 | 10.1 | Other |
| 12 hr Post dose | LS Mean | 5.3 | 2-Sided | 90 | 1.8 | 8.8 | Other |
| 16 hr Post dose | LS Mean | 7.2 | 2-Sided | 90 | 3.7 | 10.6 | Other |
| 24 hr Post dose | LS Mean | 3.3 | 2-Sided | 90 | -1.0 | 7.5 | Other |
| 0.5 hr Post dose |
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| 1 hr Post dose |
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| 1.5 hr Post dose |
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| 2 hr Post dose |
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| 2.5 hr Post dose |
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| 3 hr Post dose |
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| 4 hr Post dose |
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| 5 hr Post dose |
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| 6 hr Post dose |
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| 7 hr Post dose |
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| 8 hr Post dose |
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| 9 hr Post dose |
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| 10 hr Post dose |
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| 12 hr Post dose |
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| 16 hr Post dose |
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| 24 hr Post dose |
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|
| LS Mean |
| 6.5 |
| 2-Sided |
| 90 |
| 3.3 |
| 9.8 |
| Other |
| 1 hr Post dose | LS Mean | 4.6 | 2-Sided | 90 | 0.6 | 8.6 | Other |
| 1.5 hr Post dose | LS Mean | 4.6 | 2-Sided | 90 | 0.6 | 8.6 | Other |
| 2 hr Post dose | LS Mean | 3.8 | 2-Sided | 90 | -0.4 | 8.0 | Other |
| 2.5 hr Post dose | LS Mean | 6.1 | 2-Sided | 90 | 1.8 | 10.4 | Other |
| 3 hr Post dose | LS Mean | 5.7 | 2-Sided | 90 | 1.7 | 9.8 | Other |
| 4 hr Post dose | LS Mean | 6.2 | 2-Sided | 90 | 2.5 | 9.8 | Other |
| 5 hr Post dose | LS Mean | 5.7 | 2-Sided | 90 | 1.6 | 9.8 | Other |
| 6 hr Post dose | LS Mean | 4.8 | 2-Sided | 90 | 1.1 | 8.4 | Other |
| 7 hr Post dose | LS Mean | 3.0 | 2-Sided | 90 | -0.9 | 7.0 | Other |
| 8 hr Post dose | LS Mean | 5.0 | 2-Sided | 90 | 1.3 | 8.8 | Other |
| 9 hr Post dose | LS Mean | 6.5 | 2-Sided | 90 | 2.5 | 10.6 | Other |
| 10 hr Post dose | LS Mean | 8.6 | 2-Sided | 90 | 4.8 | 12.3 | Other |
| 12 hr Post dose | LS Mean | 7.9 | 2-Sided | 90 | 4.4 | 11.4 | Other |
| 16 hr Post dose | LS Mean | 4.9 | 2-Sided | 90 | 0.9 | 8.9 | Other |
| 24 hr Post dose | LS Mean | 7.8 | 2-Sided | 90 | 3.6 | 12.0 | Other |
| Pre dose | LS Mean | 2.1 | 2-Sided | 90 | -1.8 | 6.0 | Other |
| 0.5 hr Post dose | LS Mean | 3.1 | 2-Sided | 90 | -0.0 | 6.2 | Other |
| 1 hr Post dose | LS Mean | 1.9 | 2-Sided | 90 | -1.9 | 5.7 | Other |
| 1.5 hr Post dose | LS Mean | 6.5 | 2-Sided | 90 | 2.6 | 10.4 | Other |
| 2 hr Post dose | LS Mean | 5.3 | 2-Sided | 90 | 1.3 | 9.3 | Other |
| 2.5 hr Post dose | LS Mean | 11.1 | 2-Sided | 90 | 7.0 | 15.1 | Other |
| 3 hr Post dose | LS Mean | 9.8 | 2-Sided | 90 | 5.9 | 13.6 | Other |
| 4 hr Post dose | LS Mean | 10.7 | 2-Sided | 90 | 7.2 | 14.2 | Other |
| 5 hr Post dose | LS Mean | 8.8 | 2-Sided | 90 | 4.9 | 12.7 | Other |
| 6 hr Post dose | LS Mean | 11.0 | 2-Sided | 90 | 7.5 | 14.5 | Other |
| 7 hr Post dose | LS Mean | 10.8 | 2-Sided | 90 | 7.1 | 14.6 | Other |
| 8 hr Post dose | LS Mean | 11.3 | 2-Sided | 90 | 7.6 | 14.9 | Other |
| 9 hr Post dose | LS Mean | 9.8 | 2-Sided | 90 | 5.9 | 13.7 | Other |
| 10 hr Post dose | LS Mean | 10.5 | 2-Sided | 90 | 6.9 | 14.1 | Other |
| 12 hr Post dose | LS Mean | 11.8 | 2-Sided | 90 | 8.4 | 15.2 | Other |
| 16 hr Post dose | LS Mean | 9.4 | 2-Sided | 90 | 5.6 | 13.3 | Other |
| 24 hr Post dose | LS Mean | 10.8 | 2-Sided | 90 | 6.8 | 14.9 | Other |
| 0.5 hr Post dose |
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| 1 hr Post dose |
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| 1.5 hr Post dose |
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| 2 hr Post dose |
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| 2.5 hr Post dose |
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| 3 hr Post dose |
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| 4 hr Post dose |
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| 5 hr Post dose |
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| 6 hr Post dose |
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| 7 hr Post dose |
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| 8 hr Post dose |
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| 9 hr Post dose |
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| 10 hr Post dose |
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| 12 hr Post dose |
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| 16 hr Post dose |
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| 24 hr Post dose |
|
|
| LS Mean |
| -2.7 |
| 2-Sided |
| 90 |
| -5.9 |
| 0.5 |
| Other |
| 1 hr Post dose | LS Mean | -3.2 | 2-Sided | 90 | -5.7 | -0.7 | Other |
| 1.5 hr Post dose | LS Mean | -0.9 | 2-Sided | 90 | -3.7 | 1.9 | Other |
| 2 hr Post dose | LS Mean | -2.9 | 2-Sided | 90 | -5.7 | -0.2 | Other |
| 2.5 hr Post dose | LS Mean | -4.0 | 2-Sided | 90 | -6.5 | -1.5 | Other |
| 3 hr Post dose | LS Mean | -4.2 | 2-Sided | 90 | -7.1 | -1.3 | Other |
| 4 hr Post dose | LS Mean | -4.1 | 2-Sided | 90 | -7.4 | -0.8 | Other |
| 5 hr Post dose | LS Mean | -0.8 | 2-Sided | 90 | -3.7 | 2.1 | Other |
| 6 hr Post dose | LS Mean | -3.3 | 2-Sided | 90 | -6.3 | -0.4 | Other |
| 7 hr Post dose | LS Mean | -3.3 | 2-Sided | 90 | -6.0 | -0.5 | Other |
| 8 hr Post dose | LS Mean | -1.6 | 2-Sided | 90 | -4.7 | 1.5 | Other |
| 9 hr Post dose | LS Mean | -4.0 | 2-Sided | 90 | -6.9 | -1.2 | Other |
| 10 hr Post dose | LS Mean | -4.3 | 2-Sided | 90 | -7.6 | -1.0 | Other |
| 12 hr Post dose | LS Mean | -5.4 | 2-Sided | 90 | -8.7 | -2.1 | Other |
| 16 hr Post dose | LS Mean | -4.1 | 2-Sided | 90 | -7.4 | -0.8 | Other |
| 24 hr Post dose | LS Mean | -7.1 | 2-Sided | 90 | -10.1 | -4.2 | Other |
| Pre dose | LS Mean | 1.1 | 2-Sided | 90 | -2.0 | 4.2 | Other |
| 0.5 hr Post dose | LS Mean | 3.1 | 2-Sided | 90 | -0.1 | 6.3 | Other |
| 1 hr Post dose | LS Mean | 2.4 | 2-Sided | 90 | -0.1 | 4.9 | Other |
| 1.5 hr Post dose | LS Mean | 3.0 | 2-Sided | 90 | 0.2 | 5.8 | Other |
| 2 hr Post dose | LS Mean | 1.8 | 2-Sided | 90 | -1.0 | 4.6 | Other |
| 2.5 hr Post dose | LS Mean | 0.6 | 2-Sided | 90 | -1.9 | 3.1 | Other |
| 3 hr Post dose | LS Mean | 1.9 | 2-Sided | 90 | -1.0 | 4.8 | Other |
| 4 hr Post dose | LS Mean | -0.3 | 2-Sided | 90 | -3.5 | 3.0 | Other |
| 5 hr Post dose | LS Mean | 0.3 | 2-Sided | 90 | -2.6 | 3.2 | Other |
| 6 hr Post dose | LS Mean | -1.9 | 2-Sided | 90 | -4.8 | 1.1 | Other |
| 7 hr Post dose | LS Mean | -1.1 | 2-Sided | 90 | -3.8 | 1.7 | Other |
| 8 hr Post dose | LS Mean | -0.5 | 2-Sided | 90 | -3.6 | 2.6 | Other |
| 9 hr Post dose | LS Mean | -2.7 | 2-Sided | 90 | -5.6 | 0.2 | Other |
| 10 hr Post dose | LS Mean | -3.5 | 2-Sided | 90 | -6.8 | -0.2 | Other |
| 12 hr Post dose | LS Mean | -3.3 | 2-Sided | 90 | -6.6 | 0.1 | Other |
| 16 hr Post dose | LS Mean | 0.3 | 2-Sided | 90 | -3.0 | 3.6 | Other |
| 24 hr Post dose | LS Mean | -0.1 | 2-Sided | 90 | -3.0 | 2.9 | Other |
| 0.5 hr Post dose |
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| 1 hr Post dose |
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| 1.5 hr Post dose |
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| 2 hr Post dose |
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| 2.5 hr Post dose |
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| 3 hr Post dose |
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| 4 hr Post dose |
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| 5 hr Post dose |
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| 6 hr Post dose |
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| 7 hr Post dose |
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| 8 hr Post dose |
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| 9 hr Post dose |
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| 10 hr Post dose |
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| 12 hr Post dose |
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| 16 hr Post dose |
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| 24 hr Post dose |
|
|
| LS Mean |
| -7.3 |
| 2-Sided |
| 90 |
| -10.5 |
| -4.0 |
| Other |
| 1 hr Post dose | LS Mean | -5.0 | 2-Sided | 90 | -8.8 | -1.2 | Other |
| 1.5 hr Post dose | LS Mean | -5.0 | 2-Sided | 90 | -8.4 | -1.6 | Other |
| 2 hr Post dose | LS Mean | -3.5 | 2-Sided | 90 | -6.6 | -0.3 | Other |
| 2.5 hr Post dose | LS Mean | -2.9 | 2-Sided | 90 | -6.1 | 0.3 | Other |
| 3 hr Post dose | LS Mean | -4.6 | 2-Sided | 90 | -7.7 | -1.5 | Other |
| 4 hr Post dose | LS Mean | -7.1 | 2-Sided | 90 | -10.3 | -3.8 | Other |
| 5 hr Post dose | LS Mean | -3.2 | 2-Sided | 90 | -6.9 | 0.6 | Other |
| 6 hr Post dose | LS Mean | -4.2 | 2-Sided | 90 | -7.8 | -0.6 | Other |
| 7 hr Post dose | LS Mean | -4.8 | 2-Sided | 90 | -8.1 | -1.6 | Other |
| 8 hr Post dose | LS Mean | -4.4 | 2-Sided | 90 | -7.8 | -1.1 | Other |
| 9 hr Post dose | LS Mean | -5.9 | 2-Sided | 90 | -9.3 | -2.6 | Other |
| 10 hr Post dose | LS Mean | -4.4 | 2-Sided | 90 | -7.8 | -1.1 | Other |
| 12 hr Post dose | LS Mean | -4.2 | 2-Sided | 90 | -7.3 | -1.1 | Other |
| 16 hr Post dose | LS Mean | -5.8 | 2-Sided | 90 | -9.7 | -2.0 | Other |
| 24 hr Post dose | LS Mean | -8.2 | 2-Sided | 90 | -12.5 | -3.8 | Other |
| Pre dose | LS Mean | 2.4 | 2-Sided | 90 | -1.2 | 5.9 | Other |
| 0.5 hr Post dose | LS Mean | -1.4 | 2-Sided | 90 | -4.5 | 1.8 | Other |
| 1 hr Post dose | LS Mean | -0.4 | 2-Sided | 90 | -4.0 | 3.3 | Other |
| 1.5 hr Post dose | LS Mean | 0.3 | 2-Sided | 90 | -3.0 | 3.6 | Other |
| 2 hr Post dose | LS Mean | -1.0 | 2-Sided | 90 | -4.0 | 2.0 | Other |
| 2.5 hr Post dose | LS Mean | 0.5 | 2-Sided | 90 | -2.6 | 3.6 | Other |
| 3 hr Post dose | LS Mean | -0.7 | 2-Sided | 90 | -3.7 | 2.3 | Other |
| 4 hr Post dose | LS Mean | -2.3 | 2-Sided | 90 | -5.4 | 0.9 | Other |
| 5 hr Post dose | LS Mean | 1.1 | 2-Sided | 90 | -2.5 | 4.6 | Other |
| 6 hr Post dose | LS Mean | -0.7 | 2-Sided | 90 | -4.1 | 2.8 | Other |
| 7 hr Post dose | LS Mean | -1.9 | 2-Sided | 90 | -5.0 | 1.3 | Other |
| 8 hr Post dose | LS Mean | -0.5 | 2-Sided | 90 | -3.7 | 2.8 | Other |
| 9 hr Post dose | LS Mean | -0.1 | 2-Sided | 90 | -3.4 | 3.1 | Other |
| 10 hr Post dose | LS Mean | 0.4 | 2-Sided | 90 | -2.8 | 3.7 | Other |
| 12 hr Post dose | LS Mean | 0.1 | 2-Sided | 90 | -2.9 | 3.1 | Other |
| 16 hr Post dose | LS Mean | 0.6 | 2-Sided | 90 | -3.1 | 4.3 | Other |
| 24 hr Post dose | LS Mean | 1.7 | 2-Sided | 90 | -2.5 | 5.9 | Other |
| 0.5 hr Post dose |
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| 1 hr Post dose |
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| 1.5 hr Post dose |
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| 2 hr Post dose |
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| 2.5 hr Post dose |
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| 3 hr Post dose |
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| 4 hr Post dose |
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| 5 hr Post dose |
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| 6 hr Post dose |
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| 7 hr Post dose |
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| 8 hr Post dose |
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| 9 hr Post dose |
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| 10 hr Post dose |
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| 12 hr Post dose |
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| 16 hr Post dose |
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| 24 hr Post dose |
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|
| LS Mean |
| -0.9 |
| 2-Sided |
| 90 |
| -2.6 |
| 0.7 |
| Other |
| 1 hr post dose | LS Mean | 0.6 | 2-Sided | 90 | -1.1 | 2.3 | Other |
| 1.5 hr post dose | LS Mean | -0.1 | 2-Sided | 90 | -1.5 | 1.3 | Other |
| 2 hr post dose | LS Mean | 0.8 | 2-Sided | 90 | -0.8 | 2.4 | Other |
| 2.5 hr post dose | LS Mean | 0.7 | 2-Sided | 90 | -1.0 | 2.4 | Other |
| 3 hr post dose | LS Mean | 0.2 | 2-Sided | 90 | -1.6 | 2.0 | Other |
| 4 hr post dose | LS Mean | 0.7 | 2-Sided | 90 | -0.9 | 2.3 | Other |
| 5 hr post dose | LS Mean | 0.5 | 2-Sided | 90 | -1.2 | 2.1 | Other |
| 6 hr post dose | LS Mean | 0.9 | 2-Sided | 90 | -0.7 | 2.4 | Other |
| 7 hr post dose | LS Mean | 0.9 | 2-Sided | 90 | -0.6 | 2.4 | Other |
| 8 hr post dose | LS Mean | 0.6 | 2-Sided | 90 | -1.0 | 2.2 | Other |
| 9 hr post dose | LS Mean | -0.2 | 2-Sided | 90 | -1.6 | 1.3 | Other |
| 10 hr post dose | LS Mean | 0.0 | 2-Sided | 90 | -1.5 | 1.6 | Other |
| 12 hr post dose | LS Mean | 1.4 | 2-Sided | 90 | -0.2 | 3.0 | Other |
| 16 hr post dose | LS Mean | 1.5 | 2-Sided | 90 | -0.3 | 3.4 | Other |
| 24 hr post dose | LS Mean | -0.2 | 2-Sided | 90 | -2.1 | 1.6 | Other |
| Pre dose | LS Mean | 0.7 | 2-Sided | 90 | -1.2 | 2.6 | Other |
| 0.5 hr post dose | LS Mean | -0.3 | 2-Sided | 90 | -1.9 | 1.4 | Other |
| 1 hr post dose | LS Mean | 0.5 | 2-Sided | 90 | -1.2 | 2.2 | Other |
| 1.5 hr post dose | LS Mean | 0.7 | 2-Sided | 90 | -0.7 | 2.1 | Other |
| 2 hr post dose | LS Mean | 0.6 | 2-Sided | 90 | -1.1 | 2.2 | Other |
| 2.5 hr post dose | LS Mean | 0.8 | 2-Sided | 90 | -0.9 | 2.5 | Other |
| 3 hr post dose | LS Mean | 0.3 | 2-Sided | 90 | -1.5 | 2.1 | Other |
| 4 hr post dose | LS Mean | -0.5 | 2-Sided | 90 | -2.1 | 1.1 | Other |
| 5 hr post dose | LS Mean | 0.2 | 2-Sided | 90 | -1.5 | 1.9 | Other |
| 6 hr post dose | LS Mean | -0.2 | 2-Sided | 90 | -1.7 | 1.4 | Other |
| 7 hr post dose | LS Mean | -0.1 | 2-Sided | 90 | -1.6 | 1.4 | Other |
| 8 hr post dose | LS Mean | 0.8 | 2-Sided | 90 | -0.7 | 2.4 | Other |
| 9 hr post dose | LS Mean | -0.2 | 2-Sided | 90 | -1.6 | 1.3 | Other |
| 10 hr post dose | LS Mean | 0.1 | 2-Sided | 90 | -1.4 | 1.6 | Other |
| 12 hr post dose | LS Mean | 1.5 | 2-Sided | 90 | -0.1 | 3.1 | Other |
| 16 hr post dose | LS Mean | 1.2 | 2-Sided | 90 | -0.7 | 3.0 | Other |
| 24 hr post dose | LS Mean | 1.5 | 2-Sided | 90 | -0.3 | 3.4 | Other |
| 0.5 hr Post dose |
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| 1 hr Post dose |
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| 1.5 hr Post dose |
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| 2 hr Post dose |
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| 2.5 hr Post dose |
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| 3 hr Post dose |
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| 4 hr Post dose |
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| 5 hr Post dose |
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| 6 hr Post dose |
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| 7 hr Post dose |
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| 8 hr Post dose |
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| 9 hr Post dose |
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| 10 hr Post dose |
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| 12 hr Post dose |
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| 16 hr Post dose |
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| 24 hr Post dose |
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| LS Mean |
| -0.3 |
| 2-Sided |
| 90 |
| -1.8 |
| 1.2 |
| Other |
| 1 hr post dose | LS Mean | 1.2 | 2-Sided | 90 | -1.4 | 3.8 | Other |
| 1.5 hr post dose | LS Mean | -0.0 | 2-Sided | 90 | -1.8 | 1.8 | Other |
| 2 hr post dose | LS Mean | -1.4 | 2-Sided | 90 | -3.0 | 0.3 | Other |
| 2.5 hr post dose | LS Mean | 1.6 | 2-Sided | 90 | -0.0 | 3.1 | Other |
| 3 hr post dose | LS Mean | -0.1 | 2-Sided | 90 | -1.7 | 1.5 | Other |
| 4 hr post dose | LS Mean | 1.3 | 2-Sided | 90 | -0.3 | 2.9 | Other |
| 5 hr post dose | LS Mean | -0.1 | 2-Sided | 90 | -2.2 | 2.0 | Other |
| 6 hr post dose | LS Mean | 0.7 | 2-Sided | 90 | -0.8 | 2.3 | Other |
| 7 hr post dose | LS Mean | 0.9 | 2-Sided | 90 | -0.8 | 2.7 | Other |
| 8 hr post dose | LS Mean | 1.0 | 2-Sided | 90 | -0.3 | 2.4 | Other |
| 9 hr post dose | LS Mean | 1.1 | 2-Sided | 90 | -0.7 | 2.9 | Other |
| 10 hr post dose | LS Mean | 0.3 | 2-Sided | 90 | -1.4 | 1.9 | Other |
| 12 hr post dose | LS Mean | 1.3 | 2-Sided | 90 | -0.6 | 3.2 | Other |
| 16 hr post dose | LS Mean | 0.7 | 2-Sided | 90 | -1.0 | 2.4 | Other |
| 24 hr post dose | LS Mean | 1.6 | 2-Sided | 90 | -1.0 | 4.2 | Other |
| Pre dose | LS Mean | -0.3 | 2-Sided | 90 | -2.3 | 1.7 | Other |
| 0.5 hr post dose | LS Mean | -0.1 | 2-Sided | 90 | -1.6 | 1.3 | Other |
| 1 hr post dose | LS Mean | -1.3 | 2-Sided | 90 | -3.8 | 1.2 | Other |
| 1.5 hr post dose | LS Mean | 0.1 | 2-Sided | 90 | -1.7 | 1.8 | Other |
| 2 hr post dose | LS Mean | -1.1 | 2-Sided | 90 | -2.7 | 0.5 | Other |
| 2.5 hr post dose | LS Mean | 0.7 | 2-Sided | 90 | -0.8 | 2.3 | Other |
| 3 hr post dose | LS Mean | 0.2 | 2-Sided | 90 | -1.3 | 1.8 | Other |
| 4 hr post dose | LS Mean | 0.3 | 2-Sided | 90 | -1.2 | 1.9 | Other |
| 5 hr post dose | LS Mean | -1.5 | 2-Sided | 90 | -3.5 | 0.5 | Other |
| 6 hr post dose | LS Mean | 0.9 | 2-Sided | 90 | -0.6 | 2.3 | Other |
| 7 hr post dose | LS Mean | 0.4 | 2-Sided | 90 | -1.3 | 2.1 | Other |
| 8 hr post dose | LS Mean | 1.3 | 2-Sided | 90 | -0.0 | 2.6 | Other |
| 9 hr post dose | LS Mean | 0.4 | 2-Sided | 90 | -1.3 | 2.2 | Other |
| 10 hr post dose | LS Mean | -1.1 | 2-Sided | 90 | -2.7 | 0.5 | Other |
| 12 hr post dose | LS Mean | -0.3 | 2-Sided | 90 | -2.1 | 1.5 | Other |
| 16 hr post dose | LS Mean | -0.2 | 2-Sided | 90 | -1.9 | 1.4 | Other |
| 24 hr post dose | LS Mean | 2.3 | 2-Sided | 90 | -0.2 | 4.9 | Other |
| Relative CHFB in HR>25% |
|
| QTc>500 msec |
|
| 30<CHFB in QTc<=60 msec |
|
| CHFB in QTc>60 msec |
|
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| 1 hr Post dose |
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| 1.5 hr Post dose |
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| 2 hr Post dose |
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| 2.5 hr Post dose |
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| 3 hr Post dose |
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| 4 hr Post dose |
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| 5 hr Post dose |
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| 6 hr Post dose |
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| 7 hr Post dose |
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| 8 hr Post dose |
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| 9 hr Post dose |
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| 10 hr Post dose |
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| 12 hr Post dose |
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| 16 hr Post dose |
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| 24 hr Post dose |
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| 1 hr Post dose |
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| 1.5 hr Post dose |
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| 2 hr Post dose |
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| 2.5 hr Post dose |
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| 3 hr Post dose |
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| 4 hr Post dose |
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| 5 hr Post dose |
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| 6 hr Post dose |
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| 7 hr Post dose |
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| 8 hr Post dose |
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| 9 hr Post dose |
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| 10 hr Post dose |
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| 12 hr Post dose |
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| 16 hr Post dose |
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| 24 hr Post dose |
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