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Lincomycin

Phase 1

Bacterial Infections | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Apr 26, 2011

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01058824Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous CapsulePHASE1 COMPLETED 36 — — Apr 1, 2009Apr 1, 2009Apr 26, 20112 Brazil
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Study Endpoints
Primary Endpoints
AUC [0-t]Area under the curve of concentration vs. time, from time 0 (zero) up to the time of the last observed concentration above the limit of quantification, calculated by the trapezium rules.
1 week
Cmax Maximum reached concentration, based on the experimental data, obtained directly from the curve concentration vs. time;
1 week
Secondary Endpoints
AUC [0-¥]Area under the curve of drug concentration versus time, from time 0 (zero) extrapolated to the infinite, calculated as AUC [0-¥] = AUC [0-t] + Ct/Ke, in which Ct is the last concentration determined above the limit of
1 week
quantification.
1 week
Ke Terminal First Order Elimination Constant, estimated by the angular coefficient of the linear regression, calculated by the Least Square Method, from the natural logarithms of concentration vs. time to the last four values of concentration (or at
1 week
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
Lincomycin - Active Comparative - Hard Gelatin CapsuleACTIVE_COMPARATOR -
Lincomycin - Study Drug - Hard Gelatin CapsuleEXPERIMENTAL -
Interventions
NameTypeDescription
LincomycinDRUGSingle Dose Hard Gelatin Capsule - oral - 500 mg
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Men. * Women who are not pregnant nor nursing. * Age between 18 and 50 years-old. * Body mass index ≥ 19 and ≤ 28,5. * Good health conditions or with no significant diseases, under judgement of the legally qualified professional, according to the rules defined in the Protocol,...

Countries:Brazil
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Competitive Landscape -Bacterial Infections 62 trials
CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15, ATM-AVI, BAT, Part A: ATM-AVI Single Dose, Cohorts 1-4, PG4 vaccine in Buffer 1 with low dose PA-001
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
GSK plc Sponsored ADRGSK4PHASE2MenABCWY vaccine, iNTS-GMMA Dose C, iNTS-GMMA Dose B, iNTS-GMMA Dose A, MenACWY
Zai Lab Ltd. Sponsored ADRZLAB1PHASE3Omadacycline, Moxifloxacin
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin, Vabomere
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar, Sinovac PCV24, high-dose Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline /kg, Sulbactam /kg -Durlobactam /kg
BiomX LtdPHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Moderna, Inc.MRNA1PHASE2mRNA-1982
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 — AIGIV, CYFENDUS, Collection of samples
Abbott LaboratoriesABT1NAUndisclosed
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