PK Study of PT003 and PT001 in Japanese Healthy Subjects

NCT02196714 | Completed Phase 1 Results

• 1 other identifier: PT003010-00
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

Japanese Healthy Volunteers

Outcome Measures

Primary Outcomes (18)

• Cmax

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

  Day 1

• Cmax

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

  Day 1

• AUC 0-12

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

  Day 1

• AUC 0-12

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

  Day 1

• AUC 0-t

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

  Day 1

• AUC 0-t

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

  Day 1

• AUC 0-∞

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

  Day 1

• AUC 0-∞

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

  Day 1

• Tmax

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

  Day 1

• Tmax

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

  Day 1

• T 1/2

  Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)

  Day 1

• T 1/2

  Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)

  Day 1

• CL/F

  Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment

  Day 1

• CL/F

  Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment

  Day 1

• Vd/F

  Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment

  Day 1

• Vd/F

  Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment

  Day 1

• Lambda z

  Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment

  Day 1

• Lambda z

  Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment

  Day 1

Secondary Outcomes (15)

• 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

  12 Hours

• 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

  12 Hours

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

  12 hours

Study Arms (4)

Glycopyrronium and Formoterol Fumarate (GFF) Dose 1

EXPERIMENTAL

Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)

Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1

Glycopyrronium and Formoterol Fumarate (GFF) Dose 2

EXPERIMENTAL

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

Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 2

Glycopyrronium (GP) Dose 1

EXPERIMENTAL

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

Drug: Glycopyrronium (GP) Dose 1

Glycopyrronium (GP) Dose 2

EXPERIMENTAL

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

Drug: Glycopyrronium (GP) Dose 2

Interventions

Glycopyrronium and Formoterol Fumarate (GFF) Dose 1 DRUG

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 (GFF) Dose 2 DRUG

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 (GP) Dose 1 DRUG

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

Glycopyrronium (GP) Dose 1

Glycopyrronium (GP) Dose 2 DRUG

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

Glycopyrronium (GP) Dose 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (1)

SNBL

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Reisner C, Miller J, DePetrillo P, Maes A, Siddiqui S, Martin UJ. Pharmacokinetics and safety of a single dose of the novel LAMA/LABA fixed-dose combination of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler, formulated using co-suspension delivery technology, in Japanese healthy subjects. Pulm Pharmacol Ther. 2018 Dec;53:33-38. doi: 10.1016/j.pupt.2018.09.005. Epub 2018 Sep 13.

  PMID: 30218695 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols

Results Point of Contact

• Title: Colin Reisner, MD, FCCP, FAAAAI
• Organization: Pearl Therapeutics Inc.

creisner@pearltherapeutics.com

650-305-2600

Study Officials

• Chadwick Orevillo

  Pearl Therapeutics, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 22, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Last Updated: April 26, 2017
• Results First Posted: April 26, 2017

Record last verified: 2017-03

Locations

US (1)