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NCT Number: NCT07684586

A Study to Investigate the Difference In Blood Levels of Camlipixant Between Different Camlipixant Formulation Prototypes

This is an open-label study being conducted in healthy adults, to learn what happens to the study medicine (camlipixant) they are receiving in a person's body over time (a pharmacokinetic [PK] study). The goal of the study is to understand how the body processes camlipixant, to check its safety and how well it is tolerated. Participants will receive camlipixant at different dose levels with different formulation types either on an empty stomach or after a meal.

Why the study stopped: The study has been withdrawn given the recent decision to cease further development of camlipixant in refractory chronic cough (RCC) based on Phase 3 program results.
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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 Electrocardiogram (ECG).
  • Body weight greater than or equal (>=) 50 kilogram (kg) and body mass index (BMI) within the range 18.5 to 32.0 kilogram per meter square (kg/m^2) (inclusive).
  • A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:

i. Is a participant of non-childbearing potential (PONCBP) as defined in the full protocol.

OR ii. Is a participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of less than [<] 1 percent [%], per year

  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Must be willing and able to comply with the protocol.

Exclusion criteria

  • History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, biliary (including gallstones or previous cholecystectomy), endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, distribution, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
  • Evidence of current SARS-CoV-2, confirmed by antigen testing, prior to admission in each period.
  • Alanine transaminase (ALT) >1.0x Upper limit of normal (ULN)
  • Total bilirubin >1.0 x ULN. Participants with Gilbert's syndrome are excluded.
  • QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 millisecond (msec)
  • Participants with abnormal 12-lead ECG findings considered clinically significant by the investigator or designee at the screening visit.

Treatment and study plan

Camlipixant

Drug

Camlipixant will be administered.

Other names: GSK5464714

Primary outcomes

  1. Maximum Observed Concentration (Cmax) of Camlipixant

    Time frame: Pre-dose and up to 48 hours post dose

  2. Area Under the Curve from Zero up to 24 hours [AUC (0-24)] of Camlipixant

    Time frame: Pre-dose and up to 24 hours post dose

  3. Observed Concentration of Camlipixant at 24 hours (C24)

    Time frame: 24 hours post dose

Secondary outcomes

  1. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: Up to 26 Weeks

  2. Number of Participants Experiencing Serious Adverse Events (SAEs)

    Time frame: Up to 26 Weeks

  3. Number of Participants Experiencing Adverse Event of Special Interest (AESI)

    Time frame: Up to 26 Weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the PK and Relative Bioavailability of Different Formulation Prototypes of Camlipixant

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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