PK Study of PT003 and PT001 in Japanese Healthy Subjects

March 14, 2017 updated by: Pearl Therapeutics, Inc.

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • SNBL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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)
Drug: 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 (GFF) Dose 2
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 and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)
Experimental: Glycopyrronium (GP) Dose 1
Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)
Drug: Glycopyrronium (GP) Dose 1
Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)
Experimental: Glycopyrronium (GP) Dose 2
Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)
Drug: Glycopyrronium (GP) Dose 2
Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)
Day 1
Cmax
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)
Day 1
AUC 0-12
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)
Day 1
AUC 0-12
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)
Day 1
AUC 0-t
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)
Day 1
AUC 0-t
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)
Day 1
AUC 0-∞
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)
Day 1
AUC 0-∞
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)
Day 1
Tmax
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)
Day 1
Tmax
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)
Day 1
T 1/2
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)
Day 1
T 1/2
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)
Day 1
CL/F
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment
Day 1
CL/F
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
Day 1
Vd/F
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment
Day 1
Vd/F
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
Day 1
Lambda z
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment
Day 1
Lambda z
Time Frame: Day 1
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
12 Hours
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 (Ery. mean corpuscuar volume)
12 Hours
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 (Ery. mean corpuscuar hemoglobin)
12 Hours
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 (Erythrocytes)
12 Hours
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
12 hours
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 (eGFR)
12 hours
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 (Ferritin)
12 hours
Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose
Time Frame: 12 hours
Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose
12 hours
Change in Heart Rate From Pre-dose to 12 Hours Post Dose
Time Frame: 12 hours
Change in Heart Rate from Pre-dose to 12 hours Post dose
12 hours
Change in PR Interval From Pre-dose to 12 Hours Post Dose
Time Frame: 12 hours
Change in PR Interval from Pre-dose to 12 hours Post dose
12 hours
Change in QRS Axis From Pre-dose to 12 Hours Post Dose
Time Frame: 12 hours
Change in QRS axis from Pre-dose to 12 hours Post dose
12 hours
Change in QRS Duration From Pre-dose to 12 Hours Post Dose
Time Frame: 12 hours
Change in QRS duration from Pre-dose to 12 hours Post dose
12 hours
Change in QT Interval From Pre-dose to 12 Hours Post Dose
Time Frame: 12 hours
Change in QT Interval from Pre-dose to 12 hours Post dose
12 hours
Change in QTc Bazett 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
12 hours
Change in QTc Fridericia's 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
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pearl Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Chadwick Orevillo, Pearl Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PT003010-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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