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SB751689

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials6
Total Enrollment113
FDA Designations
No designations recorded
Clinical Trials (6)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00508534A Study To Evaluate The Effects Of Repeat Dosing Of Esomeprazole On The Pharmacokinetics Of SB-751689 In Healthy PeoplePHASE1 COMPLETED 13 — — Jul 1, 2007Aug 1, 2007May 18, 20091 Singapore
NCT00468689Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.PHASE1 COMPLETED 15 — — Apr 1, 2007Aug 1, 2007Oct 13, 20081 United States
NCT00499928A Study To Investigate The Metabolism And Excretion Of 14C SB-751689 Given To Healthy Males And Postmenopausal WomenPHASE1 COMPLETED 6 — — Apr 1, 2007Jul 1, 2007May 18, 20091 United States
NCT00540878A Study to Estimate the Effect of Formulation on the Relative Absorption of SB-751689 Administered to Healthy WomenPHASE1 COMPLETED 25 — — Apr 1, 2007 -May 18, 20091 United States
NCT00554255A Study of SB751689 in Japanese Postmenopausal WomenPHASE1 COMPLETED 18 — — Oct 23, 2006Dec 12, 2006Aug 29, 20181
NCT00388596A Study Of SB-751689, Atorvastatin, Ketoconazole, And Rosuvastatin In Health Postmenopausal Women.PHASE1 COMPLETED 36 — — Oct 1, 2006 -Oct 13, 20081 United States
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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 — 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 8 trials
CompanyTickerTrialsLead PhaseDrugs
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Precision BioSciences, Inc.DTIL1NAUndisclosed
SI-BONE, Inc.SIBN1 — Undisclosed
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