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The primary objective of this study is to evaluate the efficacy, tolerability and safety of single treatments of APL-130277 in 16 patients with Parkinson's Disease (PD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APL-130277 | Other | open label baseline comparison |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APL-130277 | Drug | Apomorphine Hydrochloride, Sublingual Thin Film |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients With Resolution of an 'OFF' Episode to an 'ON' State Following Administration of APL-130277 | Clinical confirmation of an 'OFF' state was assessed prior to dosing and confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The first full 'ON' dose was defined as the earliest dose in which a patient achieved a full 'ON' state as assessed by the Investigator. The percentage of patients who achieved their first full 'ON' is presented for each timepoint, regardless of the dose received, and for the study overall (i.e. all post-dose timepoints). | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
| Time to 'ON' State From Time of Dosing of APL-130277 | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The time to the full 'ON' state from the time of dosing in minutes was calculated from timings noted by the Investigator and recorded in the electronic case report form (eCRF). The mean time taken for a patient to reach their first full 'ON' state following administration of APL-130277 is presented for patients who turned 'ON' for the study overall. | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
| Duration of 'ON' Response From Time of Dosing of APL-130277 | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The duration of the 'ON' response was defined as the length of time in which a patient was confirmed 'ON' within a dose, and was calculated from the time noted by the Investigator and recorded in the eCRF. The mean duration of the first full 'ON' response following administration of APL-130277 is presented for patients who turned 'ON' for the study overall. | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
| Percentage of Patients Who Completed the Trial and Experienced an 'ON' Episode | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. For the overall study, the percentage of patients who completed the trial, and who experienced an 'ON' episode is presented. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in MDS-UPDRS Section III Score From Pre-dose Assessment | The Motor Function section (Section III) of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) included 33 scores based on 18-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. The percent change in the MDS-UPDRS Section III score from pre-dose to the first full ON dose or last dose for non-responders is presented. A negative change from baseline indicates an improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CNS Medical Director | Sumitomo Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Sun Health Research Institute | Sun City | Arizona | 85351 | United States | ||
| Rocky Mountain Movement Disorders Center |
23 patients were screened, 20 were assigned to treatment and 1 withdrew consent prior to treatment. 19 received APL-130277
APL-130277 sublingual film for the acute intermittent treatement of OFF episodes in PD patients
. Doses studied were 10, 15, 20, 25 and 30 milligrams (mg).
Patients with moderate to advanced Idiopathic Parkinson's Disease (PD) were recruited to this study in 4 study sites in the United States from August 2014. The study was completed in November 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | APL-130277 | At each dosing visit patients were assessed in a 'OFF' state by withholding their PD medication the night before, a dose of APL-130277 was administered. If the patient did not convert to a full 'ON' state within 3 hours and did not experience orthostatic hypotension, the next higher dose of APL-130277 was administered. If the patient did not turn ON with the next higher dose, levodopa was administered and completed their visit. Possible administered doses of APL-130277 were 10, 15, 20, 25 and 30 mg. Dosing Day 1: The starting dose was 10 mg APL-130277, and if no response 15 mg was administered. Dosing Day 2: Either the dose which elicited a response (i.e. an 'ON' state) at Day 1 was administered or the next higher dose (20 mg) was given. If no response occurred at 20 mg APL-130277, 25 mg was administered. Dosing Day 3: Either the dose which elicited a response at Day 2 was administered or the next higher dose (30 mg). If no response occurred at 30 mg the patient was discontinued. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | APL-130277 | At each dosing visit patients were assessed in a 'OFF' state by withholding their PD medication the night before, a dose of APL-130277 was administered. If the patient did not convert to a full 'ON' state within 3 hours and did not experience orthostatic hypotension, the next higher dose of APL-130277 was administered. If the patient did not turn ON with the next higher dose, levodopa was administered and completed their visit. Possible administered doses of APL-130277 were 10, 15, 20, 25 and 30 mg. Dosing Day 1: The starting dose was 10 mg APL-130277, and if no response 15 mg was administered. Dosing Day 2: Either the dose which elicited a response (i.e. an 'ON' state) at Day 1 was administered or the next higher dose (20 mg) was given. If no response occurred at 20 mg APL-130277, 25 mg was administered. Dosing Day 3: Either the dose which elicited a response at Day 2 was administered or the next higher dose (30 mg). If no response occurred at 30 mg the patient was discontinued. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Percentage of Patients With Resolution of an 'OFF' Episode to an 'ON' State Following Administration of APL-130277 | Clinical confirmation of an 'OFF' state was assessed prior to dosing and confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The first full 'ON' dose was defined as the earliest dose in which a patient achieved a full 'ON' state as assessed by the Investigator. The percentage of patients who achieved their first full 'ON' is presented for each timepoint, regardless of the dose received, and for the study overall (i.e. all post-dose timepoints). | The modified Intent-to-Treat (mITT) Population consisted of all patients who received at least 1 dose of study medication. | Posted | Number | percentage of participants | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
|
Treatment-emergent adverse events (AEs) were collected over a timeframe of approximately 3 months, with an onset at the time of or following the start of treatment with study medication and prior to 7 days after the end of treatment, or AEs which started prior to treatment but worsened at the time of or following the start of treatment.
Adverse events are presented for the Safety Population which consisted of all patients who were enrolled into the study and received at least 1 dose of study medication.
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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 | APL-130277 | At each of 3 dosing visits patients were assessed in a practically defined 'OFF' state after withholding their usual PD medications the night before and APL-130277 sublingual film was administered initially at 10 mg. If the patient did not convert to a full 'ON' state within 3 hours from initial dosing and did not experience orthostatic |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MeDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | MeDRA 17.0 | Systematic Assessment |
Due to the 90-minute sampling estimate λz values or calculate AUCinf, AUCext, or half-life as stated in the protocol was not possible.No PK parameters were calculated for subjects with fewer than 4 quantifiable concentrations following BLQ imputation
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CNS Medical Director | Sunovion Pharmaceuticals Inc. | 866-503-6351 | clinicaltrialdisclosure@sunovion.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 | Sep 10, 2014 | Jun 19, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2015 | Jun 19, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D001058 | Apomorphine |
| ID | Term |
|---|---|
| D001060 | Aporphines |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
| Pharmacokinetic (PK) Evaluation: Maximum Observed Plasma Concentration (Cmax) | The mean Cmax values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay, with a lower limit of quantification of 0.020 nanograms per millilitre (ng/mL). | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
| PK Evaluation: Time of Maximum Observed Plasma Concentration (Tmax) | The median Tmax values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
| PK Evaluation: Time to Last Analytically Quantifiable Concentration (Tlast) | The mean Tlast values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
| PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to 90 Minutes (AUC0-90) | The mean AUC0-90 values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
| PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to the Last Measurable Non-zero Concentration (AUClast) | The mean AUClast values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. The AUClast was calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method). | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
| At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
| Englewood |
| Colorado |
| 80113 |
| United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| University of South Florida Parkinson's Disease and Movement Disorders Center | Tampa | Florida | 33613 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Time to 'ON' State From Time of Dosing of APL-130277 | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The time to the full 'ON' state from the time of dosing in minutes was calculated from timings noted by the Investigator and recorded in the electronic case report form (eCRF). The mean time taken for a patient to reach their first full 'ON' state following administration of APL-130277 is presented for patients who turned 'ON' for the study overall. | The mITT Population consisted of all patients who received at least 1 dose of study medication, and data is presented for patients who turned 'ON'. | Posted | Mean | Standard Deviation | minutes | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
|
|
|
| Primary | Duration of 'ON' Response From Time of Dosing of APL-130277 | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The duration of the 'ON' response was defined as the length of time in which a patient was confirmed 'ON' within a dose, and was calculated from the time noted by the Investigator and recorded in the eCRF. The mean duration of the first full 'ON' response following administration of APL-130277 is presented for patients who turned 'ON' for the study overall. | The mITT Population consisted of all patients who received at least 1 dose of study medication, and data is presented for patients who turned 'ON'. | Posted | Mean | Standard Deviation | minutes | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
|
|
|
| Primary | Percentage of Patients Who Completed the Trial and Experienced an 'ON' Episode | Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. For the overall study, the percentage of patients who completed the trial, and who experienced an 'ON' episode is presented. | The mITT Population consisted of all patients who received at least 1 dose of study medication. | Posted | Number | percentage of participants | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
|
|
|
| Primary | Pharmacokinetic (PK) Evaluation: Maximum Observed Plasma Concentration (Cmax) | The mean Cmax values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay, with a lower limit of quantification of 0.020 nanograms per millilitre (ng/mL). | Blood draws for APL-130277 PK analyses were collected at select sites only. The PK Population consisted of all patients who had sufficient concentration-time data to derive noncompartmental PK parameters. | Posted | Mean | Standard Deviation | ng/mL | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
|
|
|
| Primary | PK Evaluation: Time of Maximum Observed Plasma Concentration (Tmax) | The median Tmax values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. | Blood draws for APL-130277 PK analyses were collected at select sites only. The PK Population consisted of all patients who had sufficient concentration-time data to derive noncompartmental PK parameters. | Posted | Median | Full Range | minutes | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
|
|
|
| Primary | PK Evaluation: Time to Last Analytically Quantifiable Concentration (Tlast) | The mean Tlast values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. | Blood draws for APL-130277 PK analyses were collected at select sites only. The PK Population consisted of all patients who had sufficient concentration-time data to derive noncompartmental PK parameters. | Posted | Mean | Standard Deviation | minutes | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
|
|
|
| Primary | PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to 90 Minutes (AUC0-90) | The mean AUC0-90 values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. | Blood draws for APL-130277 PK analyses were collected at select sites only. The PK Population consisted of all patients who had sufficient concentration-time data to derive noncompartmental PK parameters. | Posted | Mean | Standard Deviation | min*ng/mL | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
|
|
|
| Primary | PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to the Last Measurable Non-zero Concentration (AUClast) | The mean AUClast values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available. Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. The AUClast was calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method). | Blood draws for APL-130277 PK analyses were collected at select sites only. The PK Population consisted of all patients who had sufficient concentration-time data to derive noncompartmental PK parameters. | Posted | Mean | Standard Deviation | min*ng/mL | Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5. |
|
|
|
| Secondary | Percentage Change in MDS-UPDRS Section III Score From Pre-dose Assessment | The Motor Function section (Section III) of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) included 33 scores based on 18-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. The percent change in the MDS-UPDRS Section III score from pre-dose to the first full ON dose or last dose for non-responders is presented. A negative change from baseline indicates an improvement. | The mITT Population consisted of all patients who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | percent of change | At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5. |
|
|
|
| 0 |
| 19 |
| 1 |
| 19 |
| 13 |
| 19 |
| vomiting | Gastrointestinal disorders | MeDRA 17.0 | Systematic Assessment |
|
| chest discomfort | General disorders | MeDRA 17.0 | Systematic Assessment |
|
| chest pain | General disorders | MeDRA 17.0 | Systematic Assessment |
|
| fatigue | General disorders | MeDRA 17.0 | Systematic Assessment |
|
| muscle spasms | Musculoskeletal and connective tissue disorders | MeDRA 17.0 | Systematic Assessment |
|
| muscuar weakness | Musculoskeletal and connective tissue disorders | MeDRA 17.0 | Systematic Assessment |
|
| musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MeDRA 17.0 | Systematic Assessment |
|
| neck pain | Musculoskeletal and connective tissue disorders | MeDRA 17.0 | Systematic Assessment |
|
| balance disorder | Nervous system disorders | MeDRA 17.0 | Systematic Assessment |
|
| dizziness | Nervous system disorders | MeDRA 17.0 | Systematic Assessment |
|
| headache | Nervous system disorders | MeDRA 17.0 | Systematic Assessment |
|
| paraesthesia | Nervous system disorders | MeDRA 17.0 | Systematic Assessment |
|
| somnolence | Nervous system disorders | MeDRA 17.0 | Systematic Assessment |
|
| tremor | Nervous system disorders | MeDRA 17.0 | Systematic Assessment |
|
| apathy | Psychiatric disorders | MeDRA 17.0 | Systematic Assessment |
|
| nervousness | Psychiatric disorders | MeDRA 17.0 | Systematic Assessment |
|
| yawning | Respiratory, thoracic and mediastinal disorders | MeDRA 17.0 | Systematic Assessment |
|
| upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MeDRA 17.0 | Systematic Assessment |
|
| hyperhidrosis | Skin and subcutaneous tissue disorders | MeDRA 17.0 | Systematic Assessment |
|
| hot flush | Vascular disorders | MeDRA 17.0 | Systematic Assessment |
|
| orthostatic hypotension | Vascular disorders | MeDRA 17.0 | Systematic Assessment |
|
| peripheral coldness | Vascular disorders | MeDRA 17.0 | Systematic Assessment |
|
In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a mult-center publication; provided however, if a mult-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, institution and Investigator shall be free to publish.
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D007546 |
| Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
|
| 10 mg APL-130277 Dose 1 Day 2 |
|
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| 20 mg APL-130277 Dose 1 Day 2 |
|
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| 25 mg APL-130277 Dose 2 Day 2 |
|
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| 20 mg APL-130277 Dose 1 Day 3 |
|
|
| 25 mg APL-130277 Dose 1 Day 3 |
|
|
| 30 mg APL-130277 Dose 1 Day 3 |
|
|
| 25 mg APL-130277 Dose 2 Day 3 |
|
|
|
| 20 mg APL-130277 Dose 1 Day 2 |
|
|
| 20 mg APL-130277 Dose 1 Day 3 |
|
|
| 25 mg APL-130277 Dose 2 Day 3 |
|
|
|
| 10 mg APL-130277 Dose 1 Day 2 |
|
|
| 20 mg APL-130277 Dose 1 Day 2 |
|
|
| 25 mg APL-130277 Dose 2 Day 2 |
|
|
| 20 mg APL-130277 Dose 1 Day 3 |
|
|
| 25 mg APL-130277 Dose 1 Day 3 |
|
|
| 30 mg APL-130277 Dose 1 Day 3 |
|
|
| 25 mg APL-130277 Dose 2 Day 3 |
|
|
|
| 10 mg APL-130277 Dose 1 Day 2 |
|
|
| 20 mg APL-130277 Dose 1 Day 2 |
|
|
| 25 mg APL-130277 Dose 2 Day 2 |
|
|
| 20 mg APL-130277 Dose 1 Day 3 |
|
|
| 25 mg APl-130277 Dose 1 Day 3 |
|
|
| 30 mg APL-130277 Dose 1 Day 3 |
|
|
| 25 mg APL-130277 Dose 2 Day 3 |
|
|
|
| 10 mg APL-130277 Dose 1 Day 2 |
|
|
| 20 mg APL-130277 Dose 1 Day 2 |
|
|
| 25 mg APL-130277 Dose 2 Day 2 |
|
|
| 20 mg APL-130277 Dose 1 Day 3 |
|
|
| 25 mg APl-130277 Dose 1 Day 3 |
|
|
| 30 mg APl-130277 Dose 1 Day 3 |
|
|
| 25 mg APL-130277 Dose 2 Day 3 |
|
|
|
| Change from Pre-Dose to 60 min Post-Dose |
|
| Change from Pre-Dose to 90 min Post-Dose |
|