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Completed

NCT Number: NCT03075267

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

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease 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

Research Site

Shanghai, 200031, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

PT010 (BGF MDI) 320/14.4/9.6 µg

Drug

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 names: Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler

PT010 (BGF MDI) 160/14.4/9.6 µg

Drug

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 names: Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler

PT003 (GFF MDI) 14.4/9.6 µg

Drug

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 names: Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pearl Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2017
Registry last updated
Jan 19, 2021

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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