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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

PT010 (BGF MDI) 320/14.4/9.6 µg

PT010 (BGF MDI) 160/14.4/9.6 µg

PT003 (GFF MDI) 14.4/9.6 µg

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

PT010 (BGF MDI) 320/14.4/9.6 µg

PT010 (BGF MDI) 160/14.4/9.6 µg

PT003 (GFF MDI) 14.4/9.6 µg

Arm Description

PT010 Budesonide, Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg

PT010 (BGF MDI) 160/14.4/9.6 µg

PT003 (GFF MDI) 14.4/9.6 µg

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration (Cmax) - Budesonide

Maximum plasma concentration (Cmax) of Budesonide Day 1

Maximum Plasma Concentration (Cmax) - Budesonide

Maximum plasma concentration (Cmax) of Budesonide Day 8

Maximum Plasma Concentration (Cmax) - Glycopyrronium

Maximum plasma concentration (Cmax) of Glycopyrronium Day 1

Maximum Plasma Concentration (Cmax) - Glycopyrronium

Maximum plasma concentration (Cmax) of Glycopyrronium Day 8

Maximum Plasma Concentration (Cmax) - Formoterol

Maximum plasma concentration (Cmax) of Formoterol Day 1

Maximum Plasma Concentration (Cmax) - Formoterol

Maximum plasma concentration (Cmax) of Formoterol Day 8

Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide

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

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

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

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

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

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 to maximum plasma concentration (tmax) - Budesonide Day 1

Time to Maximum Plasma Concentration (Tmax) - Budesonide

Time to maximum plasma concentration (tmax) - Budesonide Day 8

Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium

Time to maximum plasma concentration (tmax) - Glycopyrronium Day 1

Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium

Time to maximum plasma concentration (tmax) - Glycopyrronium Day 8

Time to Maximum Plasma Concentration (Tmax) - Formoterol

Time to maximum plasma concentration (tmax) - Formoterol Day 1

Time to Maximum Plasma Concentration (Tmax) - Formoterol

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

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

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

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

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

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

Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Formoterol Day 1

Elimination Half-life (t½) - Budesonide

Elimination half-life (t½) - Budesonide Day 1

Elimination Half-life (t½) - Glycopyrronium

Elimination half-life (t½) - Glycopyrronium Day 1

Elimination Half-life (t½) - Formoterol

Elimination half-life (t½) - Formoterol Day 1

Apparent Total Body Clearance (CL/F) - Budesonide

Apparent total body clearance (CL/F) - Budesonide Day 1

Apparent Total Body Clearance (CL/F) - Glycopyrronium

Apparent total body clearance (CL/F) - Glycopyrronium Day 1

Apparent Total Body Clearance (CL/F) - Formoterol

Apparent total body clearance (CL/F) - Formoterol Day 1

Apparent Volume of Distribution (Vd/F) - Budesonide

Apparent volume of distribution (Vd/F) - Budesonide - Day 1

Apparent Volume of Distribution (Vd/F) - Glycopyrronium

Apparent volume of distribution (Vd/F) - Glycopyrronium - Day 1

Apparent Volume of Distribution (Vd/F) - Formoterol

Apparent volume of distribution (Vd/F) - Formoterol - Day 1

Terminal Elimination Rate Constant (λz) - Budesonide

Terminal elimination rate constant (λz) - Budesonide - Day 1

Terminal Elimination Rate Constant (λz) - Glycopyrronium

Terminal elimination rate constant (λz) - Glycopyrronium - Day 1

Terminal Elimination Rate Constant (λz) - Formoterol

Terminal elimination rate constant (λz) - Formoterol - Day 1

Accumulation Ratio for Cmax (RAC [Cmax]) - Budesonide

Accumulation ratio for Cmax (RAC [Cmax]) - Budesonide

Accumulation Ratio for Cmax (RAC [Cmax]) - Glycopyrronium

Accumulation ratio for Cmax (RAC [Cmax]) - Glycopyrronium

Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol

Accumulation ratio for Cmax (RAC [Cmax]) - Formoterol

Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide

Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide

Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium

Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium

Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol

Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol

Secondary Outcome Measures

Physical Exam Findings

Number of subjects with clinically significant changes in post baseline physical exam findings

Laboratory Tests

Number of subjects with clinically significant changes in post baseline laboratory tests

Electrocardiogram

Number of subjects with clinically significant changes in post baseline electrocardiogram

Serious Adverse Events/Adverse Events

Number of subjects with clinically significant changes in post baseline serious TEAEs (treatment-emergent adverse events) or TEAEs leading to withdrawal

Vital Signs

Number of subjects with clinically significant changes in post baseline vital signs

Full Information

NCT ID

NCT03075267

First Posted

March 6, 2017

Last Updated

December 23, 2020

Sponsor

Pearl Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03075267

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

April 17, 2017 (Actual)

Primary Completion Date

September 5, 2017 (Actual)

Study Completion Date

September 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pearl Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PT010 (BGF MDI) 320/14.4/9.6 µg

Arm Type

Experimental

Arm Description

PT010 Budesonide, Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg

Arm Title

PT010 (BGF MDI) 160/14.4/9.6 µg

Arm Type

Experimental

Arm Description

PT010 (BGF MDI) 160/14.4/9.6 µg

Arm Title

PT003 (GFF MDI) 14.4/9.6 µg

Arm Type

Experimental

Arm Description

PT003 (GFF MDI) 14.4/9.6 µg

Intervention Type

Drug

Intervention Name(s)

PT010 (BGF MDI) 320/14.4/9.6 µg

Other Intervention Name(s)

Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

PT010 (BGF MDI) 160/14.4/9.6 µg

Other Intervention Name(s)

Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler

Intervention Description

Intervention Type

Drug

Intervention Name(s)

PT003 (GFF MDI) 14.4/9.6 µg

Other Intervention Name(s)

Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler

Intervention Description

Primary Outcome Measure Information:

Title

Maximum Plasma Concentration (Cmax) - Budesonide

Description

Maximum plasma concentration (Cmax) of Budesonide Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Maximum Plasma Concentration (Cmax) - Budesonide

Description

Maximum plasma concentration (Cmax) of Budesonide Day 8

Time Frame

Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Maximum Plasma Concentration (Cmax) - Glycopyrronium

Description

Maximum plasma concentration (Cmax) of Glycopyrronium Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Maximum Plasma Concentration (Cmax) - Glycopyrronium

Description

Maximum plasma concentration (Cmax) of Glycopyrronium Day 8

Time Frame

Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Maximum Plasma Concentration (Cmax) - Formoterol

Description

Maximum plasma concentration (Cmax) of Formoterol Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Maximum Plasma Concentration (Cmax) - Formoterol

Description

Maximum plasma concentration (Cmax) of Formoterol Day 8

Time Frame

Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide

Description

Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide

Description

Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 8

Time Frame

Day 8

Title

Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium

Description

Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 1

Time Frame

Day 1

Title

Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium

Description

Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 8

Time Frame

Day 8

Title

Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol

Description

Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 1

Time Frame

Day 1

Title

Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol

Description

Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 8

Time Frame

Day 8

Title

Time to Maximum Plasma Concentration (Tmax) - Budesonide

Description

Time to maximum plasma concentration (tmax) - Budesonide Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Time to Maximum Plasma Concentration (Tmax) - Budesonide

Description

Time to maximum plasma concentration (tmax) - Budesonide Day 8

Time Frame

Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium

Description

Time to maximum plasma concentration (tmax) - Glycopyrronium Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium

Description

Time to maximum plasma concentration (tmax) - Glycopyrronium Day 8

Time Frame

Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Time to Maximum Plasma Concentration (Tmax) - Formoterol

Description

Time to maximum plasma concentration (tmax) - Formoterol Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Time to Maximum Plasma Concentration (Tmax) - Formoterol

Description

Time to maximum plasma concentration (tmax) - Formoterol Day 8

Time Frame

Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Budesonide

Description

Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Budesonide Day 1

Time Frame

Day 1

Title

Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Glycopyrronium

Description

Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Glycopyrronium Day 1

Time Frame

Day 1

Title

Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Formoterol

Description

Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Formoterol Day 1

Time Frame

Day 1

Title

Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Budesonide

Description

Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Budesonide Day 1

Time Frame

Day 1

Title

Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Glycopyrronium

Description

Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Glycopyrronium Day 1

Time Frame

Day 1

Title

Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Formoterol

Description

Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Formoterol Day 1

Time Frame

Day 1

Title

Elimination Half-life (t½) - Budesonide

Description

Elimination half-life (t½) - Budesonide Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Elimination Half-life (t½) - Glycopyrronium

Description

Elimination half-life (t½) - Glycopyrronium Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Elimination Half-life (t½) - Formoterol

Description

Elimination half-life (t½) - Formoterol Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Apparent Total Body Clearance (CL/F) - Budesonide

Description

Apparent total body clearance (CL/F) - Budesonide Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Apparent Total Body Clearance (CL/F) - Glycopyrronium

Description

Apparent total body clearance (CL/F) - Glycopyrronium Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Apparent Total Body Clearance (CL/F) - Formoterol

Description

Apparent total body clearance (CL/F) - Formoterol Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Apparent Volume of Distribution (Vd/F) - Budesonide

Description

Apparent volume of distribution (Vd/F) - Budesonide - Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Apparent Volume of Distribution (Vd/F) - Glycopyrronium

Description

Apparent volume of distribution (Vd/F) - Glycopyrronium - Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Apparent Volume of Distribution (Vd/F) - Formoterol

Description

Apparent volume of distribution (Vd/F) - Formoterol - Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Terminal Elimination Rate Constant (λz) - Budesonide

Description

Terminal elimination rate constant (λz) - Budesonide - Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Terminal Elimination Rate Constant (λz) - Glycopyrronium

Description

Terminal elimination rate constant (λz) - Glycopyrronium - Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Terminal Elimination Rate Constant (λz) - Formoterol

Description

Terminal elimination rate constant (λz) - Formoterol - Day 1

Time Frame

Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose

Title

Accumulation Ratio for Cmax (RAC [Cmax]) - Budesonide

Description

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

Title

Accumulation Ratio for Cmax (RAC [Cmax]) - Glycopyrronium

Description

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

Title

Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol

Description

Accumulation ratio for Cmax (RAC [Cmax]) - Formoterol

Time Frame

Day 1 and Day 8

Title

Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide

Description

Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide

Time Frame

Day 1 and Day 8

Title

Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium

Description

Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium

Time Frame

Day 1 and Day 8

Title

Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol

Description

Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol

Time Frame

Day 1 and Day 8

Secondary Outcome Measure Information:

Title

Physical Exam Findings

Description

Number of subjects with clinically significant changes in post baseline physical exam findings

Time Frame

Visit 4, Day 8

Title

Laboratory Tests

Description

Number of subjects with clinically significant changes in post baseline laboratory tests

Time Frame

Visit 4, Day 8

Title

Electrocardiogram

Description

Number of subjects with clinically significant changes in post baseline electrocardiogram

Time Frame

Visit 4, Day 8

Title

Serious Adverse Events/Adverse Events

Description

Number of subjects with clinically significant changes in post baseline serious TEAEs (treatment-emergent adverse events) or TEAEs leading to withdrawal

Time Frame

Visit 4, Day 8

Title

Vital Signs

Description

Number of subjects with clinically significant changes in post baseline vital signs

Time Frame

Visit 4, Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul M. Dorinsky, MD

Organizational Affiliation

Pearl Therapeutics

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200031

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

33152467

Citation

Huang Y, Assam PN, Feng C, Su R, Dorinsky P, Gillen M. Ethnic pharmacokinetic comparison of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) between Asian and Western healthy subjects. Pulm Pharmacol Ther. 2020 Oct;64:101976. doi: 10.1016/j.pupt.2020.101976. Epub 2020 Nov 2.

Results Reference

derived

PubMed Identifier

30982547

Citation

Chen Q, Hu C, Yu H, Shen K, Assam PN, Gillen M, Liu Y, Dorinsky P. Pharmacokinetics and Tolerability of Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate and Glycopyrronium/Formoterol Fumarate Dihydrate Metered Dose Inhalers in Healthy Chinese Adults: A Randomized, Double-blind, Parallel-group Study. Clin Ther. 2019 May;41(5):897-909.e1. doi: 10.1016/j.clinthera.2019.03.007. Epub 2019 Apr 11.

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=PT010010&attachmentIdentifier=aff556d3-330c-4fa8-af1a-1fd3f266eb35&fileName=PT010010_SAP_v1.0_2017-08-24_Redacted-PDF-A.pdf&versionIdentifier=

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

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