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Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects

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ClinicalTrials.gov Identifier: NCT03075267
Recruitment Status : Completed
First Posted : March 9, 2017
Results First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Brief Summary:
A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of PT003 in healthy Chinese adult subjects

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: PT010 (BGF MDI) 320/14.4/9.6 µg Drug: PT010 (BGF MDI) 160/14.4/9.6 µg Drug: PT003 (GFF MDI) 14.4/9.6 µg Phase 1

Detailed Description:
A Phase I, Randomized, Double-Blind, Parallel Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following a Single Administration and After Chronic Administration for 7 Days

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Double-Blind, Parallel-Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following A Single Administrations and After Chronic Administration for 7 Days
Actual Study Start Date : April 17, 2017
Actual Primary Completion Date : September 5, 2017
Actual Study Completion Date : September 5, 2017

Arm Intervention/treatment
Experimental: PT010 (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
Drug: PT010 (BGF MDI) 320/14.4/9.6 µg
A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
Other Name: Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler

Experimental: PT010 (BGF MDI) 160/14.4/9.6 µg
PT010 (BGF MDI) 160/14.4/9.6 µg
Drug: PT010 (BGF MDI) 160/14.4/9.6 µg
A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
Other Name: Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler

Experimental: PT003 (GFF MDI) 14.4/9.6 µg
PT003 (GFF MDI) 14.4/9.6 µg
Drug: PT003 (GFF MDI) 14.4/9.6 µg
A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
Other Name: Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) - Budesonide [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Maximum plasma concentration (Cmax) of Budesonide Day 1

  2. Maximum Plasma Concentration (Cmax) - Budesonide [ Time Frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Maximum plasma concentration (Cmax) of Budesonide Day 8

  3. Maximum Plasma Concentration (Cmax) - Glycopyrronium [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Maximum plasma concentration (Cmax) of Glycopyrronium Day 1

  4. Maximum Plasma Concentration (Cmax) - Glycopyrronium [ Time Frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Maximum plasma concentration (Cmax) of Glycopyrronium Day 8

  5. Maximum Plasma Concentration (Cmax) - Formoterol [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Maximum plasma concentration (Cmax) of Formoterol Day 1

  6. Maximum Plasma Concentration (Cmax) - Formoterol [ Time Frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Maximum plasma concentration (Cmax) of Formoterol Day 8

  7. Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 1

  8. Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide [ Time Frame: Day 8 ]
    Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 8

  9. Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium [ Time Frame: Day 1 ]
    Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 1

  10. Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium [ Time Frame: Day 8 ]
    Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 8

  11. Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol [ Time Frame: Day 1 ]
    Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 1

  12. Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol [ Time Frame: Day 8 ]
    Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 8

  13. Time to Maximum Plasma Concentration (Tmax) - Budesonide [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Time to maximum plasma concentration (tmax) - Budesonide Day 1

  14. Time to Maximum Plasma Concentration (Tmax) - Budesonide [ Time Frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Time to maximum plasma concentration (tmax) - Budesonide Day 8

  15. Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Time to maximum plasma concentration (tmax) - Glycopyrronium Day 1

  16. Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium [ Time Frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Time to maximum plasma concentration (tmax) - Glycopyrronium Day 8

  17. Time to Maximum Plasma Concentration (Tmax) - Formoterol [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Time to maximum plasma concentration (tmax) - Formoterol Day 1

  18. Time to Maximum Plasma Concentration (Tmax) - Formoterol [ Time Frame: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Time to maximum plasma concentration (tmax) - Formoterol Day 8

  19. Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Budesonide [ Time Frame: Day 1 ]
    Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Budesonide Day 1

  20. Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Glycopyrronium [ Time Frame: Day 1 ]
    Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Glycopyrronium Day 1

  21. Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Formoterol [ Time Frame: Day 1 ]
    Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Formoterol Day 1

  22. Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Budesonide [ Time Frame: Day 1 ]
    Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Budesonide Day 1

  23. Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Glycopyrronium [ Time Frame: Day 1 ]
    Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Glycopyrronium Day 1

  24. Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Formoterol [ Time Frame: Day 1 ]
    Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Formoterol Day 1

  25. Elimination Half-life (t½) - Budesonide [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Elimination half-life (t½) - Budesonide Day 1

  26. Elimination Half-life (t½) - Glycopyrronium [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Elimination half-life (t½) - Glycopyrronium Day 1

  27. Elimination Half-life (t½) - Formoterol [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Elimination half-life (t½) - Formoterol Day 1

  28. Apparent Total Body Clearance (CL/F) - Budesonide [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Apparent total body clearance (CL/F) - Budesonide Day 1

  29. Apparent Total Body Clearance (CL/F) - Glycopyrronium [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Apparent total body clearance (CL/F) - Glycopyrronium Day 1

  30. Apparent Total Body Clearance (CL/F) - Formoterol [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Apparent total body clearance (CL/F) - Formoterol Day 1

  31. Apparent Volume of Distribution (Vd/F) - Budesonide [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Apparent volume of distribution (Vd/F) - Budesonide - Day 1

  32. Apparent Volume of Distribution (Vd/F) - Glycopyrronium [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Apparent volume of distribution (Vd/F) - Glycopyrronium - Day 1

  33. Apparent Volume of Distribution (Vd/F) - Formoterol [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Apparent volume of distribution (Vd/F) - Formoterol - Day 1

  34. Terminal Elimination Rate Constant (λz) - Budesonide [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Terminal elimination rate constant (λz) - Budesonide - Day 1

  35. Terminal Elimination Rate Constant (λz) - Glycopyrronium [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Terminal elimination rate constant (λz) - Glycopyrronium - Day 1

  36. Terminal Elimination Rate Constant (λz) - Formoterol [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Terminal elimination rate constant (λz) - Formoterol - Day 1

  37. Accumulation Ratio for Cmax (RAC [Cmax]) - Budesonide [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Accumulation ratio for Cmax (RAC [Cmax]) - Budesonide

  38. Accumulation Ratio for Cmax (RAC [Cmax]) - Glycopyrronium [ Time Frame: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose ]
    Accumulation ratio for Cmax (RAC [Cmax]) - Glycopyrronium

  39. Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol [ Time Frame: Day 1 and Day 8 ]
    Accumulation ratio for Cmax (RAC [Cmax]) - Formoterol

  40. Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide [ Time Frame: Day 1 and Day 8 ]
    Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide

  41. Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium [ Time Frame: Day 1 and Day 8 ]
    Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium

  42. Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol [ Time Frame: Day 1 and Day 8 ]
    Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol


Secondary Outcome Measures :
  1. Physical Exam Findings [ Time Frame: Visit 4, Day 8 ]
    Number of subjects with clinically significant changes in post baseline physical exam findings

  2. Laboratory Tests [ Time Frame: Visit 4, Day 8 ]
    Number of subjects with clinically significant changes in post baseline laboratory tests

  3. Electrocardiogram [ Time Frame: Visit 4, Day 8 ]
    Number of subjects with clinically significant changes in post baseline electrocardiogram

  4. Serious Adverse Events/Adverse Events [ Time Frame: Visit 4, Day 8 ]
    Number of subjects with clinically significant changes in post baseline serious TEAEs (treatment-emergent adverse events) or TEAEs leading to withdrawal

  5. Vital Signs [ Time Frame: Visit 4, Day 8 ]
    Number of subjects with clinically significant changes in post baseline vital signs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Male and female Chinese subjects 18-45 years of age
  • Females of childbearing potential must agree to be abstinent or else use one of the medically acceptable forms of contraception A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception.

A male subject with female partner of child bearing potential must agree to use one additional form of medically acceptable contraception

-Be in good general health as assessed at Screening and have no clinically significant abnormal labs at Screening.

Exclusion Criteria:

  • Pregnant or nursing female subjects or subjects who are trying to conceive
  • Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
  • Subjects with a history of ECG abnormalities
  • Subjects who have cancer that has not been in complete remission for at least 5 years
  • Male subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator
  • Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
  • Males with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
  • Subjects with a diagnosis of glaucoma that in the opinion of the Investigator has not been adequately treated
  • History of substance-related disorders within 1 year of Screening
  • History of smoking or the use of nicotine containing products or electronic cigarettes within 3 months of Screening by self-reporting
  • A positive alcohol breathalyzer or urine drug screen for drugs of abuse at the Screening Visit or at the beginning of each inpatient period
  • Treatment with any prescription or non-prescription drugs (including vitamins, herbal, and dietary supplements) within 30 days
  • Positivity for human immunodeficiency virus (HIV) or Hepatitis B surface antigen (HbsAg) or positive hepatitis C antibody at Screening
  • Positive for Syphilis Antibody
  • Subjects with any flu-like syndrome or other respiratory infections
  • Recently vaccinated with an attenuated live virus

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): NCT03075267


Locations
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China
Research Site
Shanghai, China, 200031
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
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Study Director: Paul M. Dorinsky, MD Pearl Therapeutics
  Study Documents (Full-Text)

Documents provided by Pearl Therapeutics, Inc.:
Statistical Analysis Plan  [PDF] August 24, 2017
Study Protocol  [PDF] May 12, 2017

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03075267    
Other Study ID Numbers: PT010010
First Posted: March 9, 2017    Key Record Dates
Results First Posted: January 19, 2021
Last Update Posted: January 19, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Budesonide
Glycopyrrolate
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
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