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Cephalexin

Phase 4

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Oct 26, 2016

Cephalexin development status

Highest phase Phase 4 run by Abbott (NCT00234949)
Phase scored for LLYPhase 1
Registered trials 10 across 5 sponsors since Oct 2005

Cephalexin target and mechanism

ModalitySmall molecule

Also known as Keflex®, LY066873

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials5
Total Enrollment140

FDA Designations

No designations recorded

Cephalexin clinical trials

Cephalexin · 5 trials · 2 indications

Phase 1 5
NCT02490670A Study of Cephalexin Liquid in Healthy ParticipantsHealthy
COMPLETED28 Analytics
NCT02123459A Study of Cephalexin Suspension in Healthy ParticipantsHealthy Volunteers
COMPLETED28 Analytics
NCT02123472A Study of Cephalexin Liquid for Pediatrics in Healthy Adults ParticipantsHealthy Volunteers
COMPLETED28 Analytics
NCT02100826A Study of Cephalexin in Healthy ParticipantsHealthy Volunteers
COMPLETED28 Analytics
NCT02123446A Study of Cephalexin Capsules in Healthy ParticipantsHealthy Volunteers
COMPLETED28 Analytics
PHASE1COMPLETED
A Study of Cephalexin Liquid in Healthy Participants
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study of Cephalexin Suspension in Healthy Participants
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
A Study of Cephalexin Liquid for Pediatrics in Healthy Adults Participants
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
A Study of Cephalexin in Healthy Participants
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
A Study of Cephalexin Capsules in Healthy Participants
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Cephalexin Following a Single Dose
Predose, 0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.500, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period
Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin Following a Single Dose
Predose,0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose
Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period
Pharmacokinetics: Area Under the Concentration Versus Time Curve of Cephalexin From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose
Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period

Secondary Endpoints

Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin
Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period
Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum
Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cephalexin (Reference)EXPERIMENTALCephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
Cephalexin (Test)ACTIVE_COMPARATORCephalexin manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.

Interventions

NameTypeDescription
CephalexinDRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participation will be voluntary. * The body mass index of participants should be between 18-27. * Participants should have a good health status. * Limits of variation allowed within normal values at screening will be: blood pressure (seated) up to 139 millimeters of mercury (m...

Countries:Mexico
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Frequently asked questions about Cephalexin

What is Cephalexin?

Cephalexin is a small molecule drug developed by Eli Lilly and Company. It has been studied in Phase 1 clinical trials involving healthy participants. The trials evaluated different formulations, including liquid, suspension, and capsules. Cephalexin is not approved for any indication based on the available data, and its development status remains investigational.

Who makes Cephalexin?

Cephalexin is developed by Eli Lilly and Company, which trades under the ticker symbol LLY. The company has sponsored multiple Phase 1 trials of the drug in Mexico, including studies of liquid, suspension, and capsule formulations in healthy volunteers.

What phase is Cephalexin in?

Cephalexin is in Phase 1 clinical development. All five registered trials are Phase 1 studies, and they have been completed. The trials enrolled a total of 140 participants and were conducted in Mexico. No later-phase trials are listed, so the drug remains investigational.

What clinical trials is Cephalexin in?

Cephalexin has been studied in five completed Phase 1 trials, including NCT02490670, NCT02123472, NCT02123459, and NCT02123446. These trials evaluated liquid, suspension, and capsule formulations in healthy adult participants in Mexico. Each trial enrolled 28 participants, and all were active-controlled and randomized.

Is Cephalexin FDA approved?

Cephalexin is not approved by the FDA for any indication based on the available data. It is an investigational drug that has completed Phase 1 clinical trials. The trials were conducted in Mexico and involved healthy volunteers, evaluating different oral formulations of the drug.