Randomized, Crossover Safety and Pharmacokinetics Study of PT010
Study identifier:PT010003-00
ClinicalTrials.gov identifier:NCT02197975
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
COPD
Phase
Phase 1
Healthy volunteers
Yes
Study drug
PT010 Dose 1, PT010 Dose 2, Placebo MDI
Sex
All
Actual Enrollment
20
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Aug 2014
Primary Completion Date: 01 Oct 2014
Study Completion Date: 01 Oct 2014
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 May 2018 by Pearl Therapeutics, Inc.
Sponsors
Pearl Therapeutics, Inc.
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: PT010 Dose 1 PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations. | Drug: PT010 Dose 1 PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations. |
| Experimental: PT010 Dose 2 PT010 Dose 2; 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. |
| Placebo Comparator: Placebo MDI Placebo MDI. Administered as 2 inhalations | Drug: Placebo MDI Placebo MDI. Administered as 2 inhalations |
Contacts
Investigators
Principal Investigator
Chadwick Orevillo
Pearl Therapeutics
