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NCT01725685 · ClinicalTrials.gov registry record · Phase 1
To Investigate the Pharmacokinetics and Safety of Fluticasone Furoate (FF)/ Umeclidinium (UMEC) Combination Compared With FF and UMEC Monotherapies in Adult Healthy Volunteers Using a Dry Powder Inhaler (DPI)
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01725685: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01725685 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01725685, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This will be a randomized, double-blind, single-dose, three-period balanced crossover study in adult healthy subjects. Each of the 18 subjects will be randomized to receive a treatment sequence consisting of each of the three treatments (FF 400 microgram (mcg), UMEC 500 mcg and FF 400 mcg/UMEC 500 mcg), in three consecutive periods, with a wash-out period of 7 to 10 days between the periods. The study will include a Screening period (28 days prior to first dose), Treatment period (3 single dose periods separated by two 7 to 10 days washout periods) and Follow-up period (7 to 14 days post last dose). The pharmacokinetic (PK) and safety assessments will be performed during the study at fixed timepoints.
Primary Outcome
The PK parameter Cmax will be calculated for FF/UMEC in combination and as monotherapies
Interventions
- DRUG FF 400 mcg
- DRUG UMEC 500 mcg
- DRUG FF/UMEC 400/500 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-11-08 |
| Est. Completion | 2013-01-02 |
| Phase | Phase 1 |
What the finished NCT01725685 record still lists
NCT01725685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which FF 400 mcg is the first listed.
NCT01725685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01725685 about?
NCT01725685 is a clinical study titled "To Investigate the Pharmacokinetics and Safety of Fluticasone Furoate (FF)/ Umeclidinium (UMEC) Combination Compared With FF and UMEC Monotherapies in Adult Healthy Volunteers Using a Dry Powder Inhaler (DPI)". This will be a randomized, double-blind, single-dose, three-period balanced crossover study in adult healthy subjects. Each of the 18 subjects will be randomized to receive a treatment sequence consisting of each of the three treatments (FF 400 microgram (mcg), UMEC 500 mcg and FF 400 mcg/UMEC 500 m...
What is the current status of trial NCT01725685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2012-11-08. Estimated completion is 2013-01-02.
What interventions are being tested in trial NCT01725685?
The interventions under investigation include: FF 400 mcg (DRUG), UMEC 500 mcg (DRUG), FF/UMEC 400/500 mcg (DRUG).
Who is sponsoring clinical trial NCT01725685?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01725685's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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