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NCT01128634
Pharmacokinetic and Safety of GSK573719 and GW642444 Administered Individually and Concurrently, With Verapamilin in Healthy Subjects
Phase 1 trial testing GSK573719 in Pulmonary Disease, Chronic Obstructive in 32 participants. Completed in 26 April 2010.
26 April 2010
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 32 |
| Start date | 4 March 2010 |
| Primary completion | 26 April 2010 |
| Estimated completion | 26 April 2010 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- GSK573719 — full drug profile →
- GW573719/GW573719 — 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
The purpose of this study is to see if the Pharmacokinetics and the Safety Profile of GSK573719 and GSK573719/GW642444 are effected by concurrent dosing with the PGP inhibitor verapamil.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Safety, tolerability, pharmacodynamics and pharmacokinetics of umeclidinium and vilanterol alone and in combination: a randomized crossover trial.
Kelleher DL, Mehta RS, Jean-Francois BM, Preece AF, et al · · 2012 · cited 34× · PMID 23284643 · DOI 10.1371/journal.pone.0050716 -
Effect of verapamil on systemic exposure and safety of umeclidinium and vilanterol: a randomized and open-label study.
Mehta R, Kelleher D, Preece A, Hughes S, et al · · 2013 · cited 28× · PMID 23569370 · DOI 10.2147/copd.s40859 -
Evidence-based review of data on the combination inhaler umeclidinium/vilanterol in patients with COPD.
Albertson TE, Bowman WS, Harper RW, Godbout RM, et al · · 2019 · cited 3× · PMID 31239659 · DOI 10.2147/copd.s191845
Verify or expand the search:
- PubMed search for NCT01128634
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GSK573719
Trials testing the same drug.
- NCT01521377 — QTc Study GSK573719+GW642444 · Phase 1 · completed
- NCT01387230 — Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD · Phase 3 · completed
- NCT01372410 — A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Res · Phase 2 · completed
- NCT00976144 — Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of GSK573719 (LAMA) and GW642444 (LABA)Administered In · Phase 1 · completed
- NCT00515502 — Safety Study Using GSK573719 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease · Phase 2 · completed
Other recruiting trials for Pulmonary Disease, Chronic Obstructive
Currently open trials in the same condition.
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Other GlaxoSmithKline trials
Trials by the same sponsor.
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- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- 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 NCT01128634 (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: 14 June 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/NCT01128634.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing