NCT02197975

Randomized, Crossover Safety and Pharmacokinetics Study of PT010

A Phase I, Randomized, Double Blind, Placebo-Controlled, Two Period, Ascending Dose, Crossover Study to Assess the Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days.

Detailed description

This is a Phase I, single-center, randomized, double-blind, placebo-controlled, two period, ascending dose, cross-over study to assess safety and PK of two doses of PT010 in healthy adult subjects of Japanese descent. Safety and PK will be assessed following a single dose and during twice-daily (BID) chronic dosing for 7 days.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	PT010 Dose 1	PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
DRUG	PT010 Dose 2	PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
DRUG	Placebo MDI	Placebo MDI. Administered as 2 inhalations

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-07-23
• Last updated: 2014-10-28

Locations

1 site across 1 country: United States