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.
Stated in summary, eligibility criteria and outcome measures
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Clinical Research Center Hadassah Ein Kerem Medical Center
Jerusalem, Israel
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
Pharmacokinetic parameter - plasma hPTH(1-34) in pg/mL
Time frame: 6 hours
Calculation of plasma levels of hPTH(1-34) AUC0-t for each treatment regimen
Pharmacokinetic parameter - total drug exposure at different time points up to 360 min. post dose
Time frame: 6 hours
Calculation of plasma levels of hPTH(1-34) AUC0-inf for each treatment regimen
Pharmacokinetic parameter - total drug exposure in pg/mL over time from 0 extrapolated to infinity
Time frame: 6-14 hours
Calculation of plasma levels of hPTH(1-34) AUC%extrap for each treatment regimen
Pharmacokinetic parameter - Percent of AUC0-inf extrapolated to confirm reliability
Time frame: 6-14 hours
Calculation of plasma levels of hPTH(1-34) Cmax for each treatment regimen
Pharmacokinetic parameter - hPTH (1-34) maximal concentration in pg/mL (Cmax)
Time frame: 6-14 hours
Calculation of plasma levels of hPTH(1-34) Tmax for each treatment regimen
Pharmacokinetic parameter - time in minutes to reach max. concentration of hPTH(1-34)
Time frame: 6-14 hours
Calculation of plasma levels of hPTH(1-34) Kel for each treatment regimen
Pharmacokinetic parameter - elimination rate constant in pg/mL, fraction of drug eliminated per time-point up to 360 min. post dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Oral tablets
Oral tablets
Oral tablets
Oral tablets
Oral tablets
Time frame: 6 hours
Calculation of plasma levels of hPTH(1-34) t½ for each treatment regimen
Pharmacokinetic parameter - terminal elimination half life of hPTH(1-34) in minutes
Time frame: 6-14 hours
Calculation of plasma levels of hPTH(1-34) Tlast for each treatment regimen
Pharmacokinetic parameter - time of the last measurable concentration of hPTH(1-34) in minutes
Time frame: 6-14 hours
Assessment of inter-subject variability of hPTH(1-34) for each treatment regimen
Pharmacokinetic parameter - Coefficient of Variance (CV%) of hPTH (1-34)
Time frame: 6-14 hours
Calculation of dose proportionality for hPTH(1-34) for relevant treatment regimen
Pharmacokinetic parameter
Time frame: 6 hours
Assessment of the duration of exposure to hPTH(1-34) in minutes
Pharmacokinetic parameter - up to 360 min. post dose
Time frame: 6 hours
Vital Signs - body temperature (Celsius)
Safety parameter (group mean at each time point up to 360 min. post dose)
Time frame: 6 hours
Vital Signs - respiratory rate (breaths per minute)
Safety parameter (group mean at each time point up to 360 min. post dose)
Time frame: 6 hours
Vital Signs - blood pressure (systolic/diastolic mmHg)
Safety parameter (group mean at each time point up to 360 min. post dose)
Time frame: 6 hours
Vital Signs - heart rate (beats per minute)
Safety parameter (group mean at each time point up to 360 min. post dose)
Time frame: 6 hours
Incidence of Treatment-Emergent Adverse Events as assessed by the Principle Investigator
Safety parameter - AEs observed over duration of study participation
Time frame: 6-14 hours
Incidence of Serious Adverse Events (SAEs) as assessed by the Principle Investigator
Safety parameter - SAEs observed over duration of study participation
Time frame: 6-14 hours