Overview

This trial is active, not recruiting.

Condition copd
Treatments glycopyrronium and formoterol fumarate (gff) dose 1, glycopyrronium and formoterol fumarate (gff) dose 2, glycopyrronium (gp) dose 1, glycopyrronium (gp) dose 2
Phase phase 1
Sponsor Pearl Therapeutics, Inc.
Start date July 2014
End date September 2014
Trial size 24 participants
Trial identifier NCT02196714, PT003010-00

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
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 1
Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)
(Experimental)
Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)
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)
(Experimental)
Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)
glycopyrronium (gp) dose 1
Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)
(Experimental)
Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)
glycopyrronium (gp) dose 2
Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)

Primary Outcomes

Measure
Overall Pharmacokinetic profile of PT003 and PT001
time frame: 24 hour post dose

Secondary Outcomes

Measure
Overall Safety of PT003 and PT001
time frame: 24 hours post dose

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

Inclusion Criteria: Informed Consent Form (ICF) prior to any study related procedures - Male and female first generation Japanese subjects 18 to 45 years, inclusive - Good general health - Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential - Clinical labs within normal ranges or determined to be not clinically significant by the Investigator Exclusion Criteria: - Pregnancy, nursing female subjects, or subjects trying to conceive - Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study - History of ECG abnormalities - Cancer not in complete remission for at least 5 years - Clinically significant, symptomatic prostatic hypertrophy - Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening - Clinically significant bladder neck obstruction or urinary retention - Inadequately treated glaucoma - History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study - Subjects with pre-existing anemia and/or iron deficiency

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Pearl Therapeutics, Inc..