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NCT02196714 · ClinicalTrials.gov registry record · Phase 1
PK Study of PT003 and PT001 in Japanese Healthy Subjects
A Phase 1 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02196714: Completed Phase 1 study, sponsored by Pearl Therapeutics.
NCT02196714 is a Phase 1 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02196714, a Phase 1 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over, Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.
Primary Outcome
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)
Interventions
- DRUG Glycopyrronium and Formoterol Fumarate (GFF) Dose 1
- DRUG Glycopyrronium and Formoterol Fumarate (GFF) Dose 2
- DRUG Glycopyrronium (GP) Dose 1
- DRUG Glycopyrronium (GP) Dose 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-07 |
| Phase | Phase 1 |
What the finished NCT02196714 record still lists
NCT02196714 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 4 interventions - of which Glycopyrronium and Formoterol Fumarate (GFF) Dose 1 is the first listed.
NCT02196714 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02196714 about?
NCT02196714 is a clinical study titled "PK Study of PT003 and PT001 in Japanese Healthy Subjects". A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over, Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.
What is the current status of trial NCT02196714?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2014-07.
What interventions are being tested in trial NCT02196714?
The interventions under investigation include: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1 (DRUG), Glycopyrronium and Formoterol Fumarate (GFF) Dose 2 (DRUG), Glycopyrronium (GP) Dose 1 (DRUG), Glycopyrronium (GP) Dose 2 (DRUG).
Who is sponsoring clinical trial NCT02196714?
This trial is sponsored by Pearl Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02196714's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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