Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: PT003 (GFF MDI) 14.4/9.6 µgDrug: PT010 (BGF MDI) 320/14.4/9.6 µgDrug: PT010 (BGF MDI) 160/14.4/9.6 µg
- Registration Number
- NCT03075267
- Lead Sponsor
- 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
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PT003 (GFF MDI) 14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg PT003 (GFF MDI) 14.4/9.6 µg PT010 (BGF MDI) 320/14.4/9.6 µg 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 PT010 (BGF MDI) 160/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg PT010 (BGF MDI) 160/14.4/9.6 µg
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) - Formoterol 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 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) - Glycopyrronium 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-∞) - Glycopyrronium Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Formoterol Day 1 Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Formoterol Day 1
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) - Glycopyrronium Day 8
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) - Budesonide Day 1
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol Day 8 Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 8
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 to the time of the last measurable plasma concentration (AUC 0-t) - Formoterol Day 1
Apparent Total Body Clearance (CL/F) - Glycopyrronium 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 Volume of Distribution (Vd/F) - Formoterol 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 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
Maximum Plasma Concentration (Cmax) - Budesonide 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 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
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) - Budesonide Day 8
Time to Maximum Plasma Concentration (Tmax) - Budesonide 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 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
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-∞) - Budesonide Day 1
Time to Maximum Plasma Concentration (Tmax) - Formoterol 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
Elimination Half-life (t½) - Budesonide 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 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
Apparent Total Body Clearance (CL/F) - Formoterol 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 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
Elimination Half-life (t½) - Formoterol 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 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 Volume of Distribution (Vd/F) - Glycopyrronium 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
Terminal Elimination Rate Constant (λz) - Glycopyrronium 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 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 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 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 AUC 0-12 (RAC [AUC 0-12]) - Budesonide Day 1 and Day 8 Accumulation ratio for AUC 0-12 (RAC \[AUC 0-12\]) - Budesonide
Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol Day 1 and Day 8 Accumulation ratio for Cmax (RAC \[Cmax\]) - Formoterol
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium 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 Day 1 and Day 8 Accumulation ratio for AUC 0-12 (RAC \[AUC 0-12\]) - Formoterol
- Secondary Outcome Measures
Name Time Method Electrocardiogram Visit 4, Day 8 Number of subjects with clinically significant changes in post baseline electrocardiogram
Physical Exam Findings Visit 4, Day 8 Number of subjects with clinically significant changes in post baseline physical exam findings
Serious Adverse Events/Adverse Events 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 Visit 4, Day 8 Number of subjects with clinically significant changes in post baseline vital signs
Laboratory Tests Visit 4, Day 8 Number of subjects with clinically significant changes in post baseline laboratory tests
Trial Locations
- Locations (1)
Research Site
🇨🇳Shanghai, China