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SB751689

Phase 1

Osteoporosis | Small molecule | Endocrine |GSK plc|Trials Updated: Aug 29, 2018

SB751689 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials6
Total Enrollment113

FDA Designations

No designations recorded

SB751689 clinical trials

SB751689 · 6 trials · 1 indication

Phase 1 6
NCT00508534A Study To Evaluate The Effects Of Repeat Dosing Of Esomeprazole On The Pharmacokinetics Of SB-751689 In Healthy PeopleOsteoporosis
COMPLETED13 Analytics
NCT00468689Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.Osteoporosis
COMPLETED15 Analytics
NCT00499928A Study To Investigate The Metabolism And Excretion Of 14C SB-751689 Given To Healthy Males And Postmenopausal WomenOsteoporosis
COMPLETED6 Analytics
NCT00540878A Study to Estimate the Effect of Formulation on the Relative Absorption of SB-751689 Administered to Healthy WomenOsteoporosis
COMPLETED25 Analytics
NCT00554255A Study of SB751689 in Japanese Postmenopausal WomenOsteoporosis
COMPLETED18 Analytics
NCT00388596A Study Of SB-751689, Atorvastatin, Ketoconazole, And Rosuvastatin In Health Postmenopausal Women.Osteoporosis
COMPLETED36 Analytics
PHASE1COMPLETED
A Study To Evaluate The Effects Of Repeat Dosing Of Esomeprazole On The Pharmacokinetics Of SB-751689 In Healthy People
OsteoporosisUnlock trial analytics
PHASE1COMPLETED
Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.
OsteoporosisUnlock trial analytics
PHASE1COMPLETED
A Study To Investigate The Metabolism And Excretion Of 14C SB-751689 Given To Healthy Males And Postmenopausal Women
OsteoporosisUnlock trial analytics
PHASE1COMPLETED
A Study to Estimate the Effect of Formulation on the Relative Absorption of SB-751689 Administered to Healthy Women
OsteoporosisUnlock trial analytics
PHASE1COMPLETED
A Study of SB751689 in Japanese Postmenopausal Women
OsteoporosisUnlock trial analytics
PHASE1COMPLETED
A Study Of SB-751689, Atorvastatin, Ketoconazole, And Rosuvastatin In Health Postmenopausal Women.
OsteoporosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax and AUC of SB-751689 alone or after treatment with esomeprazole, and under fasted or fed conditions
over 1 week
Safety and tolerability of SB-751689 doses determined from clinical safety and tolerability data from all adverse event reporting, 12-lead ECGs, vital signs, nursing/physician observation, and safety laboratory tests
throughout the study
The total amount of administered radioactivity recovered in excreta and the primary route of excretion over 7 days
over 7 days
AUC and CMAX after a single dose.
after a single dose
Adverse events, change in clinical laboratory tests, vital signs, 12lead ECG
throughout the study
AUC and Cmax of SB-751689, rosuvastatin, and atorvastatin in blood or plasma.
throughout the study

Secondary Endpoints

Adverse event report, ECGs, vital signs, laboratory test, and clinical monitoring
over a week
PK and of SB-751689 as determined by AUC, Cmax, tmax, and half-life. PD effects (PTH, serum Ca) as determined by AUC, Emax, tmax, maximum change and % change from baseline, duration of effect, duration above ULN for PTH.
throughout the study
The amount of radioactivity associated with blood vs. plasma. The total amount radioactivity vs. SB-751689 radioactivity (metabolite vs. parent) over 7 days
over 7 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
SB-751689DRUG -
SB-751689 oral tablets (100 and 400 ng)DRUG -
Ketoconazole (NIZORAL) oral tablets (200 mg)DRUG -
SB-751689 oral tablets (400 mg)DRUG -
SB751689DRUG -
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult males or females between the ages of 21 and 55, inclusive, will be eligible for the study. Female subjects must be of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or bilateral oophorectomy ...

Countries:SingaporeUnited States
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Competitive Landscape -Osteoporosis 10 trials

No competing companies are currently tracked in active development for Osteoporosis.
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Frequently asked questions about SB751689

What is SB751689?

SB751689 is an investigational small-molecule drug candidate developed by GSK plc for osteoporosis. It has been studied in Phase 1 clinical trials, all of which are completed. It is not an approved medicine and remains in clinical development.

What is SB751689 used for in osteoporosis?

SB751689 is being investigated for the treatment of osteoporosis. Its clinical program has focused on postmenopausal women and healthy volunteers, including Japanese postmenopausal women. All six Phase 1 studies have been completed, and the drug has not been approved for any use.

Who makes SB751689?

SB751689 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 1 clinical program for the drug candidate in osteoporosis.

What phase is SB751689 in?

SB751689 is in Phase 1 clinical development. Six Phase 1 trials have been conducted and all are completed, with no active trials ongoing. The drug is investigational and has not received regulatory approval.

What clinical trials is SB751689 in?

SB751689 has been evaluated in six completed Phase 1 trials, including NCT00554255 in Japanese postmenopausal women, NCT00540878 on formulation and absorption, NCT00508534 on esomeprazole interaction, and NCT00499928 on metabolism and excretion. Total enrollment across the program was 113 participants.

Is SB751689 the same as SB-751689?

Yes, SB751689 and SB-751689 are the same drug candidate. It has also been referred to as SB-751689 oral tablets in 100 mg and 400 mg strengths, and in some listings as 100 and 400 ng. All names refer to the same GSK osteoporosis compound.