Status and phase
Conditions
Treatments
About
The purpose of this study is to characterize and compare the pharmacokinetics of hPTH(1 34) after treatment with a modified oral formulation (EBP11 and EBP22) versus two dose levels of Entera Bio's extensively studied oral EBP05 1.5 mg and 2.5 mg as well as the commercial Forteo 0.02 mg subcutaneous injection.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
History or current condition of mental instability or cognitive impairment that, in the opinion of the investigator, could compromise the validity of informed consent, compromise the safety of the participant, or lead to nonadherence with the study protocol or inability to conduct the study procedures.
Active gastrointestinal inflammatory disorder, gastrointestinal motility disorders, and chronic gastritis, including but not limited to: ulcerative colitis, Crohn's disease, irritable bowel syndrome, short bowel syndrome, celiac disease, gastroparesis, that may affect drug bioavailability.
Any conditions or factors that, in the judgment of the PI or designee, somehow may impact gastrointestinal absorption, distribution or metabolism of parathyroid hormone analogues, or known to potentiate or predispose to undesired effects.
History of significant gastrointestinal, liver or kidney disease, or gastrointestinal surgery (including bariatric surgery, or any other interventional procedures with stomach and intestinal tract) that may affect either drug bioavailability, or hPTH(1-34) or SNAC metabolism.
History or presence of alcohol or drug abuse or positive urine drug or blood alcohol results at screening.
Known allergies or sensitivities to components of the Study Medication (e.g. soy) or known hypersensitivity to PTH or hPTH(1-34).
History or presence of clinically significant:
Subjects with ECG findings deemed abnormal with clinical significance by the PI or designee at screening for the following:
Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
Seated blood pressure is less than 90 systolic or 40 diastolic mmHg or greater than 140 systolic or 90 diastolic mmHg at screening;
Orthostatic vital sign results with a decrease in systolic > 20 mmHg or decrease in diastolic > 10 mm Hg, and/or increase in heart rate of > 20 beats per minute at screening or Day 1 check-in.
Seated heart rate is lower than 50 bpm or higher than 99 bpm at screening (when clinically significant as determined by PI).
Estimated creatinine clearance < 80 mL/min at screening
Unable to refrain from or anticipates the use of:
Donation of blood or significant blood loss within 56 days prior to first dosing.
Hemoglobin levels below 13 g/dL at screening or at in screening test done during the study.
Plasma donation within 7 days prior to first dosing.
Participation in another interventional clinical study within 30 days prior to screening visit.
Primary purpose
Allocation
Interventional model
Masking
45 participants in 14 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal