CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Glycopyrronium and Formoterol Fumarate (GFF) Dose 1 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02196714
NCT02196714Phase 1Completed
CompareCT.gov

A Phase I, Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001 in Japanese Healthy Subjects

Pearl Therapeutics, Inc.·interventional·Posted Jul 22, 2014·Updated Apr 26, 2017

In Brief

A Phase 1 clinical trial evaluating Glycopyrronium and Formoterol Fumarate (GFF) Dose 1, Glycopyrronium and Formoterol Fumarate (GFF) Dose 2, and 2 other interventions for COPD. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 22, 2014
Enrollment StartJul 1, 2014
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.9 years ago

Interventions

Glycopyrronium and Formoterol Fumarate (GFF) Dose 1drug

Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)

Glycopyrronium and Formoterol Fumarate (GFF) Dose 2drug

Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)

Glycopyrronium (GP) Dose 1drug

Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)

Glycopyrronium (GP) Dose 2drug

Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)