Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Sub… (NCT05965167) | Clinical Trial Compass
CompletedPhase 1
Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo
Israel45 participantsStarted 2023-05-11
Plain-language summary
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.
Who can participate
Age range18 Years – 35 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy male subjects, 18 - 35 years of age, inclusive, at screening.
✓. Continuous nonsmoker who has not used nicotine containing products (including e-cigarettes, vapors, etc.) for at least 12 months prior to first dosing and throughout the study, based on subject self-reporting.
✓. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
✓. Medically healthy with no clinically significant medical condition, physical examination, laboratory profiles, vital signs, orthostatic vital sign measurements, or ECGs, as deemed by the PI or designee to be relevant to the study and does not pose an additional risk to the subject by their participation in the study.
✓. Understands the study procedures described in the Informed Consent Form (ICF), be willing and able to comply with the protocol, and provides written consent.
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.
What they're measuring
1
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
2
Calculation of plasma levels of hPTH(1-34) AUC0-t for each treatment regimen
Timeframe: 6 hours
3
Calculation of plasma levels of hPTH(1-34) AUC0-inf for each treatment regimen
Timeframe: 6-14 hours
4
Calculation of plasma levels of hPTH(1-34) AUC%extrap for each treatment regimen
Timeframe: 6-14 hours
5
Calculation of plasma levels of hPTH(1-34) Cmax for each treatment regimen
Timeframe: 6-14 hours
6
Calculation of plasma levels of hPTH(1-34) Tmax for each treatment regimen
Timeframe: 6-14 hours
7
Calculation of plasma levels of hPTH(1-34) Kel for each treatment regimen
✕. 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:
Calculation of plasma levels of hPTH(1-34) t½ for each treatment regimen
Timeframe: 6-14 hours
9
Calculation of plasma levels of hPTH(1-34) Tlast for each treatment regimen
Timeframe: 6-14 hours
10
Assessment of inter-subject variability of hPTH(1-34) for each treatment regimen
Timeframe: 6-14 hours
11
Calculation of dose proportionality for hPTH(1-34) for relevant treatment regimen
Timeframe: 6 hours
12
Assessment of the duration of exposure to hPTH(1-34) in minutes
Timeframe: 6 hours
13
Vital Signs - body temperature (Celsius)
Timeframe: 6 hours
14
Vital Signs - respiratory rate (breaths per minute)