The purpose of this study is to characterize and compare the pharmacokinetics of hPTH(1 34) after treatment with modified oral formulations (EBP11, EBP11-F1, EBP11-F2, EBP11-F4, EBP11-F5 and EBP22) versus three dose levels of Entera Bio's extensively studied oral EBP05 1.5 mg, 2.5 mg and 3.0 mg as well as the commercial Forteo 0.02 mg subcutaneous injection.
Age range
18 Years – 35 Years
Sex
MALE
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Assessment of the pharmacokinetic profile of plasma hPTH(1-34) after single or twice daily oral administration for treatment regimen as listed under Arms and Interventions at 5, 10, 15, 20, 40, 50, 60, 75, 90, 105, 120, 180, 240, 360 min. post dose
Timeframe: 6 hours
Calculation of plasma levels of hPTH(1-34) AUC0-t for each treatment regimen
Timeframe: 6 hours
Calculation of plasma levels of hPTH(1-34) AUC0-inf for each treatment regimen
Timeframe: 6-14 hours
Calculation of plasma levels of hPTH(1-34) AUC%extrap for each treatment regimen
Timeframe: 6-14 hours
Calculation of plasma levels of hPTH(1-34) Cmax for each treatment regimen
Timeframe: 6-14 hours
Calculation of plasma levels of hPTH(1-34) Tmax for each treatment regimen
Timeframe: 6-14 hours
Calculation of plasma levels of hPTH(1-34) Kel for each treatment regimen
Timeframe: 6 hours
Calculation of plasma levels of hPTH(1-34) t½ for each treatment regimen
Timeframe: 6-14 hours
Calculation of plasma levels of hPTH(1-34) Tlast for each treatment regimen
Timeframe: 6-14 hours
Assessment of inter-subject variability of hPTH(1-34) for each treatment regimen
Timeframe: 6-14 hours
Calculation of dose proportionality for hPTH(1-34) for relevant treatment regimen
Timeframe: 6 hours
Assessment of the duration of exposure to hPTH(1-34) in minutes
Timeframe: 6 hours
Vital Signs - body temperature (Celsius)
Timeframe: 6 hours
Vital Signs - respiratory rate (breaths per minute)
Timeframe: 6 hours
Vital Signs - blood pressure (systolic/diastolic mmHg)
Timeframe: 6 hours
Vital Signs - heart rate (beats per minute)
Timeframe: 6 hours
Incidence of Treatment-Emergent Adverse Events as assessed by the Principle Investigator
Timeframe: 6-14 hours
Incidence of Serious Adverse Events (SAEs) as assessed by the Principle Investigator
Timeframe: 6-14 hours