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PK Study of PT003 and PT001 in Japanese Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02196714
Recruitment Status : Completed
First Posted : July 22, 2014
Results First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
COPD Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1 Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 2 Drug: Glycopyrronium (GP) Dose 1 Drug: Glycopyrronium (GP) Dose 2 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : July 2014
Actual Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. Cmax [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)

  2. Cmax [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)

  3. AUC 0-12 [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)

  4. AUC 0-12 [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)

  5. AUC 0-t [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)

  6. AUC 0-t [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)

  7. AUC 0-∞ [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)

  8. AUC 0-∞ [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)

  9. Tmax [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)

  10. Tmax [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)

  11. T 1/2 [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)

  12. T 1/2 [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)

  13. CL/F [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment

  14. CL/F [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment

  15. Vd/F [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment

  16. Vd/F [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment

  17. Lambda z [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment

  18. Lambda z [ Time Frame: Day 1 ]
    Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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)

  7. 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)

  8. 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

  9. 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

  10. 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

  11. 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. 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

  13. 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

  14. 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

  15. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196714


Locations
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United States, Maryland
SNBL
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
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Study Chair: Chadwick Orevillo Pearl Therapeutics, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02196714    
Other Study ID Numbers: PT003010-00
First Posted: July 22, 2014    Key Record Dates
Results First Posted: April 26, 2017
Last Update Posted: April 26, 2017
Last Verified: March 2017
Keywords provided by Pearl Therapeutics, Inc.:
Japanese Healthy Volunteers
Additional relevant MeSH terms:
Layout table for MeSH terms
Glycopyrrolate
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
 Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents