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

NCT07684586 | Suspended Phase 1 FDA Drug

• 1 other identifier: 223643
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cough

Keywords

Camlipixant; GSK5464714; Cough; Refractory Chronic Cough; Unexplained Chronic Cough; Pharmacokinetics; Safety; Tolerability; Prototypes; Healthy

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Concentration (Cmax) of Camlipixant

  Pre-dose and up to 48 hours post dose

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

  Pre-dose and up to 24 hours post dose

• Observed Concentration of Camlipixant at 24 hours (C24)

  24 hours post dose

Secondary Outcomes (3)

• Number of Participants Experiencing Adverse Events (AEs)

  Up to 26 Weeks

• Number of Participants Experiencing Serious Adverse Events (SAEs)

  Up to 26 Weeks

• Number of Participants Experiencing Adverse Event of Special Interest (AESI)

  Up to 26 Weeks

Study Arms (2)

Treatment Sequence 1

EXPERIMENTAL

Participants will receive camlipixant according to the following sequence: formulation A at dose level 1 (fasted) formulation B at dose level 1 (fasted); formulation C at dose level 2 (fasted); formulation A at dose level 4 (fasted); and formulation A at dose level 1 (fed).

Drug: Camlipixant

Treatment Sequence 2

EXPERIMENTAL

Participants will receive camlipixant according to the following sequence: formulation A at dose level 1 (fasted) formulation B at dose level 1 (fasted); formulation C at dose level 3 (fasted); formulation A at dose level 4 (fasted); and formulation A at dose level 4 (fed).

Drug: Camlipixant

Interventions

Camlipixant DRUG

Camlipixant will be administered.

Also known as: GSK5464714

Treatment Sequence 1; Treatment Sequence 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Cough; Chronic Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 2, 2026
• Primary Completion (Estimated): August 27, 2027
• Study Completion (Estimated): August 27, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

GB (1)