NCT02262689

To Evaluate Effects of GSK2256294 on Pulmonary Artery Pressure in Healthy Volunteers Under Normoxic and Hypoxic Conditions

Completed Phase 1 Last updated 9 May 2017

What this trial tests

Phase 1 trial testing GSK2256294 in Pulmonary Disease, Chronic Obstructive in 30 participants. Completed in 24 April 2015.

Timeline

8 January 2015

Primary endpoint
24 April 2015

24 April 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	8 January 2015
Primary completion	24 April 2015
Estimated completion	24 April 2015
Sites	1 location across United States

Drugs / interventions tested

• GSK2256294 — full drug profile →
• Placebo

Conditions studied

• Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study evaluates the effect of GSK2256294 exposure at steady state on pulmonary artery systolic pressure (PASP) in healthy volunteers, under hypoxic conditions, after 7 days of dosing. It is single centre, double blind, randomized, placebo-controlled study to be conducted in approximately 30 healthy volunteers. Subjects will be screened no more than 30 days. Subject will be admitted in clinical unit on Day -1. Subject will be dosed for 7 days in unit in morning on all days except for dosing on Days 3 -6. Dosing on Days 3 -6 will occur at home. Subjects will return to the unit on the evening of Day 6 and remain there until Day 8. Subjects will undergo echocardiography under normoxic and hypoxic on Day 1 pre-dose and on Day 7 post-dose. Subject will be followed up for 28- 32 days after discharge. The maximum estimated time that a subject will be enrolled in the study is 62 days from the screening visit to follow up.

Publications & conference data

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

1. Small-molecule discovery through DNA-encoded libraries.
   Peterson AA, Liu DR. · · 2023 · cited 145× · PMID 37328653 · DOI 10.1038/s41573-023-00713-6
2. In vitro and in vivo metabolism of N-adamantyl substituted urea-based soluble epoxide hydrolase inhibitors.
   Liu JY, Tsai HJ, Morisseau C, Lango J, et al · · 2015 · cited 9× · PMID 26494425 · DOI 10.1016/j.bcp.2015.10.013
3. Soluble epoxide hydrolase: a next-generation drug target for Alzheimer's disease and related dementias.
   Gregory A, Tang C, Fan F. · · 2025 · cited 7× · PMID 39503424 · DOI 10.4103/nrr.nrr-d-24-00503
4. Spatiotemporal application of small molecules in fracture healing.
   Sui H, Wu Z, Xiong Z, Zhang H, et al · · 2025 · PMID 41623945 · DOI 10.12336/bmt.24.00087