Phase 1
Completed N=30
A Study to Assess the PK and Safety of PT010 in Subjects With COPD Following Single and Repeat Dose
Source: ClinicalTrials.gov NCT03250182 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) - Budesonide — 709.3 pg/mL
Summary
This is a Phase I open-label, single center study to assess the PK and safety of BGF MDI 320/14.4/9.6 µg in subjects with moderate to severe COPD. Pharmacokinetics will be assessed following a single dose administration on the first treatment day (Day 1) and will be assessed again after 7 days of repeat dosing. This study includes a Screening Period of up to 28 days and a single Treatment Period of 8 days. A follow-up phone call will be conducted at least 5 days but no longer than 7 days after the last dose of study drug.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) - Budesonide |
663.2 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) - Glycopyrronium |
18.3 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) - Formoterol |
7.4 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide |
3004.7 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium |
73.9 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol |
47.4 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Budesonide |
2731.8 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Glycopyrronium |
39.4 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Formoterol |
33.4 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) - Budesonide |
0.33; 0.67 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium |
0.03; 0.10 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) - Formoterol |
0.33; 0.67 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Budesonide |
2996.9 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Glycopyrronium |
61.2 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Formoterol |
46.0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Given their signed written informed consent to participate.
- Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
- Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS), or other local applicable guidelines.
- Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
- Pre-bronchodilator FEV1/FVC ratio must be <0.70 and pre-bronchodilator FEV1 must be ≥50% and <80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations
Key Exclusion Criteria
- Significant diseases or conditions to : other than COPD, active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease and uncontrolled sleep apnea .
- Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
- Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
- Subjects who have a history of hypersensitivity to any corticosteroid,
- β2-agonist, muscarinic anticholinergic, or any component of the MDI
- Alpha-1 antitrypsin deficiency as the cause of COPD
Data sourced from ClinicalTrials.gov (NCT03250182). 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.