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PTH

Phase 1

Drug Safety and Bioavailability | Small molecule | Other |Entera Bio Ltd.|Last Updated: Jan 10, 2018

Target and mechanism

ModalitySmall molecule

Also known as Oral PTH (1-34)

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

PTH · 1 trial · 1 indication

Phase 1 1
NCT02571140A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy SubjectsDrug Safety and Bioavailability
COMPLETED30 Analytics
PHASE1COMPLETED
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects
Drug Safety and Bioavailability
NCT0257114030
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Study Endpoints

Primary Endpoints

Peak Plasma Concentration
60-522 days

Blood samples for determination of PTH plasma concentrations will be taken at the time points to study the pharmocokinetc profile

Secondary Endpoints

Adverse Events
60-522 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Active ComparatorACTIVE_COMPARATORSubcutaneous injection of Teriparatide
Oral PTH (1-34)EXPERIMENTALOral administration of pill with API with different optimizations

Interventions

NameTypeDescription
TeriparatideDRUGsubcutaneous standard injection
Oral PTH (1-34)DRUGDifferent optimization of API
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Eligibility Criteria

Age Range18 Years to 50 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: 1. Signed Informed consent to the study. 2. Males ,aged 18 - 50 years, BMI 18-30 kg/m2, inclusive, 3. Subjects able to adhere to the visit schedule and protocol requirements 4. Hematology ,Chemistry and Urinalysis values with no clinical significance or do not reflect a medical ...

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