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Completed

NCT Number: NCT02196714

PK Study of PT003 and 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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SNBL

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 2

Drug

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

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 2

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pearl Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
First posted
Jul 22, 2014
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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