PK Study of PT003 and PT001 in Japanese Healthy Subjects

Phase 1

Completed

• Conditions: COPD
• Interventions: Drug: Glycopyrronium (GP) Dose 1; Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1; Drug: Glycopyrronium (GP) Dose 2; Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 2

• Registration Number: NCT02196714
• Lead Sponsor: Pearl Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-18
• Study First Posted: 2014-07-22
• Primary Completion: 2014-09
• Results First Submitted: 2016-05-24
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-14
• Last Update Submitted: 2017-03-14
• Results First Posted: 2017-04-26
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
AUC 0-∞	Day 1	Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)
Vd/F	Day 1	Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
Cmax	Day 1	Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)
AUC 0-12	Day 1	Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)
Tmax	Day 1	Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)
CL/F	Day 1	Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
AUC 0-t	Day 1	Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)
T 1/2	Day 1	Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)
Lambda z	Day 1	Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment

Secondary Outcome Measures

Name	Time	Method
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose	12 Hours	Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Erythrocytes)
Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose	12 hours	Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose
Change in Heart Rate From Pre-dose to 12 Hours Post Dose	12 hours	Change in Heart Rate from Pre-dose to 12 hours Post dose
Change in PR Interval From Pre-dose to 12 Hours Post Dose	12 hours	Change in PR Interval from Pre-dose to 12 hours Post dose
Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose	12 hours	Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose
Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose	12 hours	Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose	12 hours	Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ferritin)
Change in QRS Axis From Pre-dose to 12 Hours Post Dose	12 hours	Change in QRS axis from Pre-dose to 12 hours Post dose
Change in QRS Duration From Pre-dose to 12 Hours Post Dose	12 hours	Change in QRS duration from Pre-dose to 12 hours Post dose
Change in QT Interval From Pre-dose to 12 Hours Post Dose	12 hours	Change in QT Interval from Pre-dose to 12 hours Post dose

Trial Locations

Locations (1)

SNBL; 🇺🇸 Baltimore, Maryland, United States