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This Phase I study will be performed in a double-blind, randomized, crossover design in healthy male and female subjects. The central ECG laboratory will be blinded to treatment. Every effort will be made to enroll equal numbers of males and females into the study.
Eligible subjects will participate in a screening phase (within 28 days of the dosing day), a treatment phase and a final visit, which will be conducted on discharge from the study. Study duration will be 32 days with a total of approximately 12 days of confinement. During the resting ECG periods, 12-lead digital ECGs will be extracted from continuous telemetry at selected time points to assess potential ECG effects. Blood samples for PK evaluation will be collected in conjunction with the ECG time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APF530 Exposure, Granisetron and Moxifloxacin, Placebo | Arm 1:APF530 Exposure Arm 2:Granisetron IV Arm 3:Moxifloxacin Arm 4:Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Withdraw treatment | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| QTc Prolongation | To evaluate the effect of APF530 given subcutaneously, in normal volunteers, on placebo subtracted change of QTcF | From baseline over 48 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of granisetron | To achieve a mean Cmax of granisetron and AUC exposure in normal volunteers equivalent to that achieved by APF530 given subcutaneously, in patients. | From baseline over 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Male and Female Subjects
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| Name | Affiliation | Role |
|---|---|---|
| Albert Dietz, MD, PhD | Spaulding Clinical Research LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Clinical Research | West Bend | Wisconsin | 53095 | United States |
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| ID | Term |
|---|---|
| D028761 | Withholding Treatment |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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