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PTH134

Phase 1

Post-menopausal Osteoporosis | Small molecule | Endocrine |Novartis AG|Trials Updated: May 13, 2011

PTH134 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since May 2008

PTH134 target and mechanism

ModalitySmall molecule

Also known as teriparatid

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment136

FDA Designations

No designations recorded

PTH134 clinical trials

PTH134 · 2 trials · 2 indications

Phase 1 2
NCT01224717Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal WomenPost-menopausal Osteoporosis
COMPLETED104 Analytics
NCT00676312Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal SubjectsPostmenopausal Osteoporosis
COMPLETED32 Analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Doses of PTH134 in Post-menopausal Women
Post-menopausal OsteoporosisUnlock trial analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effect of PTH134 at Increasing Doses in Healthy Postmenopausal Subjects
Postmenopausal OsteoporosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Measure: Effects of treatment on bone biomarkers. Measure levels of PINP, CTX-1, and serum calcium levels, serum phosphate, P1CP, bone-specific alkaline phosphatase, osteocalcin.
12 weeks
•Safety and tolerability of ascending single doses of PTH134 over 24 hours as compared to baseline. •Pharmacokinetics after ascending single doses of PTH134, including comparison with reference drug Forteo 20 µg sc over 24 hours.

Secondary Endpoints

Change from baseline in serum calcium levels after 12 weeks of treatment
12 weeks
•Assessment of PK from PTH134 formulations over 24 hours. •Assessment of the pharmacodynamic profile of serum ionized calcium, total serum calcium, bone biomarkers with reference drug Forteo 20 µg and placebo over 24 hours.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PTH134EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
ForsteoACTIVE_COMPARATOR -
1EXPERIMENTALCross-over treatment with increasing doses of PTH134, placebo and active comparator.

Interventions

NameTypeDescription
PTH134DRUG -
PlaceboDRUG -
ForsteoDRUG -
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Eligibility Criteria

Age Range45 Years to 80 Years
SexFEMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Post-menopausal women osteoporotic/osteopenic with an additional risk factor 45 to 80 years old Exclusion Criteria: * Use of estrogen or hormone replacement therapy * Use of parathormone or parathormone fragments, calcitonin, aluminum supplements, within 12 months prior to f...

Countries:DenmarkGermanySwitzerland
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Frequently asked questions about PTH134

What is PTH134 used for?

PTH134 is an investigational small molecule being developed for postmenopausal osteoporosis, a condition that weakens bones in women after menopause. It is in Phase 1 clinical development and has not been approved by the FDA.

Who is developing PTH134?

PTH134 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is currently in Phase 1 clinical trials.

What phase is PTH134 in?

PTH134 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and the drug remains investigational, meaning it has not received regulatory approval.

What clinical trials is PTH134 in?

PTH134 has been studied in two completed Phase 1 trials. One trial, NCT00676312, enrolled 32 healthy postmenopausal subjects in Switzerland. Another trial, NCT01224717, enrolled 104 postmenopausal women in Denmark and Germany.

Is PTH134 the same as any other drug?

PTH134 is the sole name used for this investigational drug in clinical trials. No alternative names have been reported for this compound.