Phase 1
Completed N=96
Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects
Source: ClinicalTrials.gov NCT03075267 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) - Budesonide — 459.308; 224.298 pg/mL
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) - Budesonide |
626.435; 315.425 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) - Glycopyrronium |
11.303; 11.754; 13.124 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) - Formoterol |
16.125; 16.945; 17.710 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide |
2509.888; 1249.615 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium |
69.487; 77.078; 72.636 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol |
81.936; 85.322; 83.499 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) - Budesonide |
0.333; 0.333 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium |
0.333; 0.333; 0.333 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) - Formoterol |
0.100; 0.100; 0.100 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Budesonide |
1884.912; 830.012 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Glycopyrronium |
17.616; 17.707; 20.287 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Formoterol |
48.326; 47.408; 45.950 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Budesonide |
1936.211; 876.673 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Glycopyrronium |
35.465; 33.014; 43.537 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Formoterol |
61.617; 73.123; 70.608 | — |
| PRIMARY Elimination Half-life (t½) - Budesonide |
4.572; 3.168 | — |
| PRIMARY Elimination Half-life (t½) - Glycopyrronium |
5.676; 8.539; 6.194 | — |
| PRIMARY Elimination Half-life (t½) - Formoterol |
5.098; 5.657; 5.628 | — |
| PRIMARY Apparent Total Body Clearance (CL/F) - Budesonide |
165.271; 182.508 | — |
| PRIMARY Apparent Total Body Clearance (CL/F) - Glycopyrronium |
406.038; 436.184; 330.757 | — |
| PRIMARY Apparent Total Body Clearance (CL/F) - Formoterol |
155.801; 131.286; 135.962 | — |
| PRIMARY Apparent Volume of Distribution (Vd/F) - Budesonide |
1090.237; 834.269 | — |
| PRIMARY Apparent Volume of Distribution (Vd/F) - Glycopyrronium |
2172.038; 2123.999; 1864.314 | — |
| PRIMARY Apparent Volume of Distribution (Vd/F) - Formoterol |
1125.215; 1000.172; 1035.257 | — |
| PRIMARY Terminal Elimination Rate Constant (λz) - Budesonide |
0.152; 0.219 | — |
| PRIMARY Terminal Elimination Rate Constant (λz) - Glycopyrronium |
0.122; 0.081; 0.112 | — |
| PRIMARY Terminal Elimination Rate Constant (λz) - Formoterol |
0.136; 0.123; 0.123 | — |
| PRIMARY Accumulation Ratio for Cmax (RAC [Cmax]) - Budesonide |
1.400; 1.406 | — |
| PRIMARY Accumulation Ratio for Cmax (RAC [Cmax]) - Glycopyrronium |
2.383; 2.319; 2.412 | — |
| PRIMARY Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol |
1.678; 1.706; 1.668 | — |
| PRIMARY Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide |
1.455; 1.539 | — |
| PRIMARY Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium |
3.324; 3.030; 3.189 | — |
| PRIMARY Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol |
1.718; 1.835; 1.620 | — |
| SECONDARY Physical Exam Findings |
0; 0; 0 | — |
| SECONDARY Laboratory Tests |
0; 1; 0 | — |
| SECONDARY Electrocardiogram |
0; 0; 0 | — |
| SECONDARY Serious Adverse Events/Adverse Events |
0; 0; 0 | — |
| SECONDARY Vital Signs |
2; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT03075267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.