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Phase 1 Completed N=56 Randomized Treatment

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

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