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

Terminated Phase 1 Last updated 13 September 2018

What this trial tests

Phase 1 trial testing GSK2793660 solution in Bronchiectasis in 33 participants. Terminated before completion.

Timeline

28 January 2014

Primary endpoint
31 October 2014

31 October 2014

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	triple
Primary purpose	treatment
Enrollment	33
Start date	28 January 2014
Primary completion	31 October 2014
Estimated completion	31 October 2014
Sites	1 location across United Kingdom

Drugs / interventions tested

• GSK2793660 solution — full drug profile →
• GSK2793660 capsule
• Placebo solution
• Placebo capsule

Conditions studied

• Bronchiectasis — all drugs for Bronchiectasis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 55, any sex, with Bronchiectasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Epithelial desquamation observed in a phase I study of an oral cathepsin C inhibitor (GSK2793660).
   Miller BE, Mayer RJ, Goyal N, Bal J, et al · · 2017 · cited 44× · PMID 28800383 · DOI 10.1111/bcp.13398
2. Targets of Neutrophil Influx and Weaponry: Therapeutic Opportunities for Chronic Obstructive Airway Disease.
   Mårdh CK, Root J, Uddin M, Stenvall K, et al · · 2017 · cited 22× · PMID 28596972 · DOI 10.1155/2017/5273201
3. Cathepsin C in health and disease: from structural insights to therapeutic prospects.
   Chitsamankhun C, Siritongtaworn N, Fournier BPJ, Sriwattanapong K, et al · · 2024 · cited 15× · PMID 39164687 · DOI 10.1186/s12967-024-05589-7
4. Dipeptidyl peptidase-1 inhibitors in bronchiectasis.
   Johnson E, Gilmour A, Chalmers JD. · · 2025 · cited 5× · PMID 40533102 · DOI 10.1183/16000617.0257-2024
5. Dipeptidyl peptidase 1 inhibitors and neutrophilic inflammation in bronchiectasis: a narrative review.
   Tang RD, Yue JQ, Chalmers JD, Guan WJ. · · 2025 · cited 1× · PMID 40809229 · DOI 10.21037/jtd-2025-289