PK Study of PT003 and PT001 in Japanese Healthy Subjects

Phase 1CompletedNCT02196714

Pearl Therapeutics, Inc.24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

COPD

Interventions

Glycopyrronium and Formoterol Fumarate (GFF) Dose 1DRUG

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 2DRUG

Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)

Glycopyrronium (GP) Dose 1DRUG

Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

SNBL

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Cmax

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)

Time frame: Day 1

Cmax

Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)

Time frame: Day 1

AUC 0-12

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)

Time frame: Day 1

AUC 0-12

Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)

Time frame: Day 1

AUC 0-t

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)

Time frame: Day 1

AUC 0-t

Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)

Time frame: Day 1

AUC 0-∞

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)

Time frame: Day 1

AUC 0-∞

Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)

Time frame: Day 1

Tmax

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)

Time frame: Day 1

Data from ClinicalTrials.gov

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Secondary Outcomes

Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose

Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose

Time frame: 12 Hours

Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose

Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar volume)

Time frame: 12 Hours

Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose

Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar hemoglobin)

Time frame: 12 Hours

Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose

Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Erythrocytes)

Time frame: 12 Hours

Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose

Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose

Time frame: 12 hours

Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose

Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (eGFR)

Time frame: 12 hours

Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose

Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ferritin)

Time frame: 12 hours

Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose

Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose

Time frame: 12 hours

Change in Heart Rate From Pre-dose to 12 Hours Post Dose

Change in Heart Rate from Pre-dose to 12 hours Post dose

Time frame: 12 hours

Change in PR Interval From Pre-dose to 12 Hours Post Dose

Change in PR Interval from Pre-dose to 12 hours Post dose

Time frame: 12 hours

Change in QRS Axis From Pre-dose to 12 Hours Post Dose

Change in QRS axis from Pre-dose to 12 hours Post dose

Time frame: 12 hours

Change in QRS Duration From Pre-dose to 12 Hours Post Dose

Change in QRS duration from Pre-dose to 12 hours Post dose

Time frame: 12 hours

Change in QT Interval From Pre-dose to 12 Hours Post Dose

Change in QT Interval from Pre-dose to 12 hours Post dose

Time frame: 12 hours

Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose

Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose

Time frame: 12 hours

Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose

Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose

Time frame: 12 hours