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GSK5464714- Camlipixant

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

GSK5464714- Camlipixant · 1 trial · 1 indication

Phase 1 1
NCT06497517A Study to Investigate the Effect of Food on Camlipixant Concentrations in Healthy ParticipantsCough
COMPLETED14 Analytics
PHASE1COMPLETED
A Study to Investigate the Effect of Food on Camlipixant Concentrations in Healthy Participants
CoughUnlock trial analytics

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 to 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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Frequently asked questions about GSK5464714- Camlipixant

What is GSK5464714-Camlipixant used for?

GSK5464714-Camlipixant is an investigational small molecule being developed for the treatment of cough. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in healthy participants to evaluate its effects, with a focus on respiratory conditions.

Who makes GSK5464714-Camlipixant?

GSK5464714-Camlipixant is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.

What phase is GSK5464714-Camlipixant in?

GSK5464714-Camlipixant is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied in early-stage trials to assess its safety, tolerability, and how it is processed by the body.

What clinical trials is GSK5464714-Camlipixant in?

GSK5464714-Camlipixant has one completed Phase 1 clinical trial registered under NCT06497517. This study, titled 'A Study to Investigate the Effect of Food on Camlipixant Concentrations in Healthy Participants,' enrolled 14 participants in the United States and evaluated the drug's concentrations after food intake.

Is GSK5464714-Camlipixant the same as Camlipixant?

Yes, GSK5464714-Camlipixant is also known as Camlipixant. The drug is referred to by both names in clinical and research contexts. It is a small molecule being developed for cough and is currently in Phase 1 clinical trials.