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GSK5464714- Camlipixant

Phase 1

Cough | Small molecule | Other |GSK plc|Last Updated: Feb 7, 2025

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06497517A Study to Investigate the Effect of Food on Camlipixant Concentrations in Healthy ParticipantsPHASE1 COMPLETED 14Jul 9, 2024Aug 26, 2024Feb 7, 20251 United States
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Study Endpoints
Primary Endpoints
Area Under the Plasma Concentration-Time Curve (AUC) from Time Zero to Infinity Post-Dose [AUC(0-inf)
Up to Day 3 for each period
Maximum Observed Plasma Drug Concentration (Cmax)
Up to Day 3 for each period
Secondary Endpoints
Time to Maximum Observed Plasma Drug Concentration (Tmax)
Up to Day 3 for each period
Apparent Terminal Phase Half-Life (t½)
Up to Day 3 for each period
Apparent Oral Clearance (CL/F)
Up to Day 3 for each period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sequence 1EXPERIMENTALIn sequence 1, eligible participants will be randomly assigned to 1 of 2 sequences to receive single dose of GSK5464714- Camlipixant on Day 1 under fasting condition (Treatment A), followed by single dose of GSK5464714 in fed condition (Treatment B). There will be a washout period of minimum 7 days between each period.
Sequence 2EXPERIMENTALIn sequence 2, eligible participants will be randomly assigned to 1 of 2 sequences to receive single dose of GSK5464714- Camlipixant on Day 1 in fed condition (Treatment B), followed by single dose of GSK5464714 under fasting condition (Treatment A). There will be a washout period of minimum 7 days between each period.
Interventions
NameTypeDescription
GSK5464714- CamlipixantDRUGGSK5464714- Camlipixant will be administered
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead ECGs including the following: * Seat...

Countries:United States
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