Single Dose PK Study in Non-Naïve Beagle or Mixed Breed Dogs (Parallel Session)
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1 Single PK Study in Non-Naïve Beagle or Mixed Breed Dogs (Parallel Session) Single PK Study in Non-Naïve Beagle or Mixed Breed Dogs (4 crossover Sessions) Repeat PK Study in Non-Naïve Beagle or Mixed Breed Dogs
2 Single PK Study in Non-Naïve Beagle or Mixed Breed Dogs (Parallel Session) Groups Test material Animals per group Group Route Approx. Time points A TBD 2M/2F xx mg/kg TBD B TBD 2M/2F xx mg/kg TBD Approximately 8 time points up to 24 post-dose Total Animals: 8 beagle or mixed breed dogs (non-naïve) No. of Sessions: One session does in parallel Frequency: Single dose Route: To be specified (ex. oral, bolus iv, infusion, subcutaneous injection, intraperitoneal injection, topical ocular, etc.) Formulation: Per Sponsor specifications Collection Times: Standard collection time points are within normal working hours, 8:00am-5:00pm Monday through Friday. Sponsor-specified collections (i.e. 12 or 18 hour) outside of standard business hours will incur additional charges. Blood Processing: Whole blood samples will be collected and immediately placed on wet ice until processed. A portion of each blood sample will be processed as specified by Sponsor. Samples will be directly transferred to appropriate tubes and stored at -80 ± 10 C. Samples will be shipped to Sponsor for analysis. Deliverables: Summary table with animal designation of dose group and collection time points 2
3 3 Single PK Study in Non-Naïve Beagle or Mixed Breed Dogs (4 Crossover Sessions) Species Beagle or mixed breed Dogs Dosing N of animals Route Session Frequency 1 1x 2 1x 3M/3F TBD 3 1x 4 1x (mg/kg) TBD Blood Collection Time Points Approximately 8 time points up to 24 post-dose Total Animals: Estimated 6 dogs (non-naïve) No. of Sessions: 4 Sessions Washout Period: As specified by Sponsor; minimum of 48 hours between doses Frequency: Single dose Route: To be specified (ex. oral, bolus iv, infusion, subcutaneous injection, intraperitoneal injection, topical ocular, etc.) Formulation: Per Sponsor specifications Collection Times: Standard collection time points are within normal working hours, 8:00am-5:00pm Monday through Friday. Sponsor-specified collections (i.e. 12 or 18 hour) outside of standard business hours will incur additional charges. Blood Processing: Whole blood samples will be collected and immediately placed on wet ice until processed. A portion of each blood sample will be processed as specified by Sponsor. Samples will be directly transferred to appropriate tubes and stored at -80 ± 10 C. Samples will be shipped to Sponsor for analysis. Deliverables: Summary table with animal designation of dose group and collection time points
4 Repeat PK Study in Non-Naïve Beagle or Mixed Breed Dogs Species Beagle or mixed breed dogs No. of animals 4M/4F Route As requested Frequency Once daily for 5-7 days Sample Collection Clinical Pathology TK Collection Time Points Pre-dose and post-final dose Post-final dose for approximately 6 time points (ex. 0.5, 1, 2, 4, 8 and 24 hours) Total Animals: 8 Dogs (non-naïve) Frequency: Daily for 5-7 days Route: To be specified (ex. oral, bolus iv, infusion, subcutaneous injection, intraperitoneal injection, topical ocular, etc.) Formulation: Per Sponsor specifications Clinical Pathology: As specified by Sponsor. Options include clinical chemistry, hematology, coagulation, and/or reticulocytes. TK Blood Processing: Whole blood samples will be collected and immediately placed on wet ice until processed. A portion of each blood sample will be processed as specified by Sponsor. Samples will be directly transferred to appropriate tubes and stored at -80 ± 10 C. Samples will be shipped to Sponsor for analysis. Deliverables: Report with observations and dose administration table for in-life phase. 4
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