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Cathelicidin, hCAP-18, FALL-39, CAP-18

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Overview Studies Clinical Trials

Terminated PHASE1 INTERVENTIONAL NCT02058407

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Food Effect of Single or Repeat Doses of GSK2793660 in Healthy Subjects

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This study is the first administration of GSK2793660 to humans and will evaluate the safety, tolerability, PK and PD of single oral ascending doses of GSK2793660, and of repeat oral doses of GSK2793660 in healthy subjects. The study will comprise two parts (Part A and Part B). Part A will consist of two cohorts of subjects, each taking part in a three-way cross over study, with ascending doses of GSK2793660 and placebo. Available safety, PK and PD data will be reviewed before each dose escalation. This will be followed by a food-effect arm in the cohort that received what is deemed to be the target clinical dose. Part B is planned to consist of up to two cohorts of subjects, each taking part in one 14 day repeat dose study period. Subjects will be dosed on Day 1 and then on Days 3-15. It is planned that two doses will be evaluated. The dose(s) to be tested will be selected based on safety, PK, and PD from Part A. The study is intended to provide sufficient confidence in the safety profile of the molecule and information on target engagement to allow progression to further studies.

Interventions

Name: GSK2793660 solution

Type: DRUG

Description: Clear, colourless solution at a unit dose strength of 0.1 mg/mL, in a glass bottle

Name: GSK2793660 capsule

Type: DRUG

Description: Size zero swedish orange capsule at a unit dose of 3 mg, 10 mg, 20 mg and 50 mg

Name: Placebo solution

Type: DRUG

Description: Matching placebo to GSK2793660 solution

Name: Placebo capsule

Type: DRUG

Description: Matching placebo to GSK2793660 capsule

Primary Outcomes

Measure: Safety and tolerability of GSK2793660 as assessed by vital signs in Part A and Part B

TimeFrame: Part A: Screening (SCR), Day 1 (Pre-dose, 0.25 hours (h), 0.5 h, 1.5 h, 2 h, 3 h, 4 h, 12 h), Day 2 (24 h), Day 3 (48 h), Day 4 (72 h) in each period and at follow-up (7-14 days post last dose); Part B: SCR, Day 1 to Day 18 and at follow-up

Description: Vital sign measurements will include systolic and diastolic blood pressure, pulse rate, respiratory rate and oral body temperature

Measure: Safety and tolerability of GSK2793660 as assessed by cardiac telemetry in Part A and Part B

TimeFrame: Part A: From 1 h pre-dose on Day 1 until 24 h post dose on Day 2 in each period. Part B: From 1 h prior to dosing on Day 3 until pre-dose on Day 5

Description: Continuous cardiac telemetry will be performed in Part A and Part B of the study

Measure: Safety and tolerability of GSK2793660 as assessed by electrocardiograms (ECGs) in Part A and Part B

TimeFrame: Part A: SCR, Day 1 (Pre-dose, 0.25 h, 0.5 h, 1.5 h, 2 h, 3 h, 4 h, 12 h), Day 2 (24 h), Day 3 (48 h), Day 4 (72 h) in each period and at follow-up (7-14 days post last dose); Part B: SCR, Day 1 to Day 18 and at follow-up

Description: Cardiac safety will be assessed by 12-lead ECGs

Measure: Safety and tolerability of GSK2793660 as assessed by laboratory data in Part A and Part B

TimeFrame: Part A: SCR, Day -1, Day 1 (8 h), Day 2 (24 h), Day 4 (72 h) in each period and at follow-up (7-14 days post last dose); Part B: SCR, Day -1, Day 2, Day 4, Day 10, Day 15, Day 18 and at follow-up

Description: Laboratory assessments will include hematology, clinical chemistry and urinalysis parameters

Measure: Safety and tolerability of GSK2793660 as assessed by adverse events (AEs) in Part A and Part B

TimeFrame: Part A: Approximately 22- 24 weeks. Part B: Approximately 9 weeks

Description:

Trial Information

NCT ID

NCT02058407

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

GlaxoSmithKline

Last Updated

December 15, 2025