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NCT00866515
Drug Interaction Study to Investigate Co-administration of GW642444M With Ketoconazole
Phase 1 trial testing Ketoconazole + GW642444M in Pulmonary Disease, Chronic Obstructive in 20 participants. Completed in 27 March 2009.
27 March 2009
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 22 December 2008 |
| Primary completion | 27 March 2009 |
| Estimated completion | 27 March 2009 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- Ketoconazole + GW642444M — full drug profile →
- Placebo + GW642444M — full drug profile →
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
This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover study in healthy male and female subjects. There will be two treatment periods each consisting of 7 days. During each treatment period subjects will receive single doses of ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the morning of Day 5.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The effect of ketoconazole on the pharmacokinetics and pharmacodynamics of inhaled fluticasone furoate and vilanterol trifenatate in healthy subjects.
Kempsford R, Allen A, Bal J, Rubin D, et al · · 2013 · cited 18× · PMID 23116485 · DOI 10.1111/bcp.12019 -
Spotlight on fluticasone furoate/vilanterol trifenatate for the once-daily treatment of asthma: design, development and place in therapy.
Albertson TE, Bullick SW, Schivo M, Sutter ME. · · 2016 · cited 7× · PMID 28008228 · DOI 10.2147/dddt.s113573
Verify or expand the search:
- PubMed search for NCT00866515
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT00866515 (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: 18 July 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/NCT00866515.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing