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