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NCT02006537
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of GSK2256294 in Healthy Young Males and Elderly Subjects
Phase 1 trial testing GSK2256294 in Pulmonary Disease, Chronic Obstructive in 28 participants. Completed in 27 May 2014.
27 May 2014
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 31 January 2014 |
| Primary completion | 27 May 2014 |
| Estimated completion | 27 May 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
- GSK2256294 — full drug profile →
Conditions studied
- Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
18 and older, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will investigate the safety and pharmacokinetics (PK) of a single dose of GSK2256294 in healthy young and elderly subjects to explore the effects of food, gender and age on drug exposure. The biliary metabolites in healthy young males will be investigated using the Entero-test after a single oral dose of GSK2256294. This study will be conducted in two cohorts (Cohort 1 and Cohort 2). Cohort 1 is open label in order to characterise the PK profile of GSK2256294 in healthy young males and also to investigate the biliary metabolites of GSK2256294. Cohort 2 uses a crossover design to allow comparison of the PK parameters of GSK2256294 between in the fed and fasted state within subject and also to compare the PK parameters of GSK2256294 between male and female subjects. A washout period of a minimum of 2 weeks has been chosen to allow and adequate washout of GSK2256294.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pharmacokinetics, pharmacodynamics and adverse event profile of GSK2256294, a novel soluble epoxide hydrolase inhibitor.
Lazaar AL, Yang L, Boardley RL, Goyal NS, et al · · 2016 · cited 137× · PMID 26620151 · DOI 10.1111/bcp.12855 -
Exported Epoxide Hydrolases Modulate Erythrocyte Vasoactive Lipids during Plasmodium falciparum Infection.
Spillman NJ, Dalmia VK, Goldberg DE. · · 2016 · cited 29× · PMID 27795395 · DOI 10.1128/mbio.01538-16 -
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 -
Upregulated Nuclear Expression of Soluble Epoxide Hydrolase Predicts Poor Outcome in Breast Cancer Patients: Importance of the Digital Pathology Approach.
Montecillo-Aguado M, Soca-Chafre G, Antonio-Andres G, Morales-Martinez M, et al · · 2024 · cited 2× · PMID 39125591 · DOI 10.3390/ijms25158024
Verify or expand the search:
- PubMed search for NCT02006537
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GSK2256294
Trials testing the same drug.
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- NCT03318783 — Subarachnoid Hemorrhage and Soluble Epoxide Hydrolase Inhibition Trial · Phase 1, PHASE2 · completed
- NCT02262689 — To Evaluate Effects of GSK2256294 on Pulmonary Artery Pressure in Healthy Volunteers Under Normoxic and Hypoxic Conditio · Phase 1 · completed
- NCT01762774 — A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2256294 in Healt · Phase 1 · completed
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Currently open trials in the same condition.
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Other GlaxoSmithKline trials
Trials by the same sponsor.
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- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02006537 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 9 May 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02006537.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing