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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.

Tracking Information
First Submitted Date  ICMJE March 6, 2017
First Posted Date  ICMJE March 9, 2017
Results First Submitted Date  ICMJE June 11, 2020
Results First Posted Date  ICMJE January 19, 2021
Last Update Posted Date January 19, 2021
Actual Study Start Date  ICMJE April 17, 2017
Actual Primary Completion Date September 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol [ Time Frame: Day 1 and Day 8 ]
    Accumulation ratio for Cmax (RAC [Cmax]) - Formoterol
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
  • Maximum plasma concentration (Cmax) [ Time Frame: Day 1 and Day 8 ]
  • Area under the plasma concentration-time curve from 0-12 hours (AUC0-12) [ Time Frame: Day 1 and Day 8 ]
  • Time to maximum plasma concentration (tmax) [ Time Frame: Day 1 and Day 8 ]
  • Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) [ Time Frame: Day 1 ]
  • Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-inf) [ Time Frame: Day 1 ]
  • Elimination half-life (t½) [ Time Frame: Day 1 ]
  • Apparent total body clearance (CL/F) [ Time Frame: Day 1 ]
  • Apparent volume of distribution (Vd/F) [ Time Frame: Day 1 ]
  • Terminal elimination rate constant (λz) [ Time Frame: Day 1 ]
  • Accumulation ratio for Cmax (RAC [Cmax]) [ Time Frame: Day 1 and Day 8 ]
  • Accumulation ratio for AUC0-12 (RAC [AUC0-12]) [ Time Frame: Day 1 and Day 8 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2020)
  • Physical Exam Findings [ Time Frame: Visit 4, Day 8 ]
    Number of subjects with clinically significant changes in post baseline physical exam findings
  • Laboratory Tests [ Time Frame: Visit 4, Day 8 ]
    Number of subjects with clinically significant changes in post baseline laboratory tests
  • Electrocardiogram [ Time Frame: Visit 4, Day 8 ]
    Number of subjects with clinically significant changes in post baseline electrocardiogram
  • 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
  • Vital Signs [ Time Frame: Visit 4, Day 8 ]
    Number of subjects with clinically significant changes in post baseline vital signs
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2017)
  • Number of patients with abnormal findings in physical examination [ Time Frame: Day -1 and Day 8 ]
  • Number of patients with clinically significant changes in laboratory tests [ Time Frame: Day -1 and Day 8 ]
  • Number of patients with clinically significant changes in electrocardiogram [ Time Frame: Day -1 and Day 8 ]
  • Number of patients with clinically significant adverse events [ Time Frame: Day 1 through Day 12-14 ]
    (Day -28 through Day 12-14, only for randomized subjects)
  • Number of patients with clinically significant changes in vital signs [ Time Frame: Day -1 and Day 8 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects
Official Title  ICMJE 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
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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: PT010 (BGF MDI) 320/14.4/9.6 µg
  • Experimental: PT010 (BGF MDI) 160/14.4/9.6 µg
    PT010 (BGF MDI) 160/14.4/9.6 µg
    Intervention: Drug: PT010 (BGF MDI) 160/14.4/9.6 µg
  • Experimental: PT003 (GFF MDI) 14.4/9.6 µg
    PT003 (GFF MDI) 14.4/9.6 µg
    Intervention: Drug: PT003 (GFF MDI) 14.4/9.6 µg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2018)
96
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2017)
90
Actual Study Completion Date  ICMJE September 5, 2017
Actual Primary Completion Date September 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03075267
Other Study ID Numbers  ICMJE PT010010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Pearl Therapeutics, Inc.
Study Sponsor  ICMJE Pearl Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paul M. Dorinsky, MD Pearl Therapeutics
PRS Account Pearl Therapeutics, Inc.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP