NCT02196714

PK Study of PT003 and PT001 in Japanese Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Glycopyrronium and Formoterol Fumarate (GFF) Dose 1	Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)
DRUG	Glycopyrronium and Formoterol Fumarate (GFF) Dose 2	Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)
DRUG	Glycopyrronium (GP) Dose 1	Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)
DRUG	Glycopyrronium (GP) Dose 2	Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-09-01
• First posted: 2014-07-22
• Last updated: 2017-04-26
• Results posted: 2017-04-26

Locations

1 site across 1 country: United States