Phase 1
Completed N=56
A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010
Source: ClinicalTrials.gov NCT03311373 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Maximum Plasma Concentration (Cmax)-Budesonide — 702.3; 452.6; 340.0; 612.0 pg/mL
Summary
Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax)-Budesonide |
702.3; 452.6; 340.0; 612.0 | — |
| PRIMARY Maximum Plasma Concentration (Cmax)-Glycopyrronium |
47.7; 19.0; 17.1; 42.1 | — |
| PRIMARY Maximum Plasma Concentration (Cmax)-Formoterol |
18.1; 10.8; 8.3; 17.9 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide |
1934.0; 1452.8; 823.9; 1618.5 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Glycopyrronium |
74.3; 48.1; 19.8; 69.2 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Formoterol |
35.9; 37.0; 8.9; 33.1 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax)-Budesonide |
0.33; 0.33; 0.33; 0.33 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium |
0.03; 0.03; 0.03; 0.03 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax)-Formoterol |
0.10; 0.10; 0.10; 0.10 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide |
2132.1; 1491.8; 823.9; 1806.2 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium |
40.4; 65.9; 15.2; 39.2 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Formoterol |
63.2; 62.7; 62.6; 62.0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Signed and dated Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before any protocol-specific screening procedures are performed
- Male and female subjects 18 to 40 years of age, inclusive
- Be in good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation
- Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal, or surgically sterile
- Male subjects who are sexually active must agree to use a double-barrier method of contraception (condom with spermicide) from the first dose of randomized study drug until 2 weeks after their last dose, and must not donate sperm during their study participation period
- Screening laboratory tests must be within normal range or determined to not be clinically significant by the Investigator.
- Demonstrate correct MDI administration technique
Key Exclusion Criteria
- For female subjects, a positive serum human chorionic gonadotropin (hCG) test at screening or a positive urine hCG at admission for any of the 4 Treatment Periods
- 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 who have cancer that has not been in complete remission for at least 5 years
- Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to screening
- Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
- History of substance-related disorders (with the exception of caffeine-related and nicotine-related disorders) within 1 year of screening
- History of smoking or the use of nicotine-containing products within 3 months of screening by self-reporting
- A positive alcohol breathalyzer or urine drug screen for drugs of abuse at screening or at the beginning of each Treatment Period
- Treatment with any prescription or non-prescription drugs including vitamins, herbal, and dietary supplements for 28 days or 5 half-lives, whichever is longer, before study drug use
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening Period
- Subjects with any flu-like syndrome or other respiratory infections within 2 weeks of drug administration or who have been vaccinated with an attenuated live virus within 4 weeks of drug administration
- Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (eg, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)
Data sourced from ClinicalTrials.gov (NCT03311373). 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.