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Lincomycin

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Lincomycin · 1 trial · 1 indication

Phase 1 1
NCT01058824Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous CapsuleBacterial Infections
COMPLETED36 Analytics
PHASE1COMPLETED
Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule
Bacterial Infections
NCT0105882436
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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 to 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 61 trials

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
GSK plc Sponsored ADRGSK4PHASE2MenABCWY vaccine
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline/kg
BiomX Inc.PHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
Moderna, Inc.MRNA1PHASE2mRNA-1982
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 - AIGIV
Abbott LaboratoriesABT1N/AUndisclosed
CareDx, Inc.CDNA1 - Undisclosed
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Frequently asked questions about Lincomycin

What is Lincomycin used for?

Lincomycin is a small molecule antibiotic used for the treatment of bacterial infections. It is being developed by Pfizer, Inc. for this indication. The drug is currently in Phase 1 clinical development, meaning it is investigational and has not yet been approved for commercial use.

Who makes Lincomycin?

Lincomycin is being developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is in Phase 1 clinical development for the treatment of bacterial infections.

What phase is Lincomycin in?

Lincomycin is in Phase 1 clinical development. It is an investigational drug for the treatment of bacterial infections and has not yet been approved by regulatory authorities. One Phase 1 clinical trial has been completed to evaluate the drug.

What clinical trials is Lincomycin in?

Lincomycin has one completed Phase 1 clinical trial registered under NCT01058824. The study was a relative bioavailability study of two lincomycin hydrochloride hard gelatinous capsules, conducted in Brazil with 36 participants, including healthy volunteers aged 18 years and older.

Is Lincomycin the same as Lincomycin Hydrochloride?

Lincomycin is the active drug, and it is often formulated as lincomycin hydrochloride for oral administration. The clinical trial NCT01058824 evaluated lincomycin hydrochloride hard gelatinous capsules, indicating that the hydrochloride salt form is used in the drug product being studied.