Phase 1
Completed N=28
Green (Sustainable) VENTOLIN - Pharmacokinetics (PK) Study in Healthy Participants
Source: ClinicalTrials.gov NCT05791565 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol — 0.622; 0.536 Hour*nanogram/milliliter (h*ng/mL)
Summary
This study will be conducted to compare the PK of salbutamol administered via metered dose inhalers (MDI) containing propellants 1,1-difluroethane (HFA-152a) and 1,1,1,2-tetrafluoroethane (HFA-134a) in healthy participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC (0-30 Min)) of Salbutamol |
0.622; 0.536 | — |
| PRIMARY AUC From Time 0 to Infinity (AUC[0-inf]) of Salbutamol |
21.1; 15.0 | — |
| PRIMARY AUC From Time 0 to Time t (AUC[0-t]) of Salbutamol |
19.0; 13.7 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Salbutamol |
2.36; 1.80 | — |
| SECONDARY Time to Cmax (Tmax) of Salbutamol |
2.00; 1.50 | — |
| SECONDARY Apparent Terminal Phase Half-life (t1/2) of Salbutamol |
7.650; 7.297 | — |
| SECONDARY Minimum Observed Serum Potassium Level (Emin, K) After Dosing of Salbutamol |
3.94; 3.96 | — |
| SECONDARY Weighted Mean Serum Potassium (0-4 Hour) (AUEC, K) |
4.15; 4.17 | — |
| SECONDARY Maximum Observed Heart Rate (Emax, HR) After Dosing of Salbutamol |
74.2; 73.4 | — |
| SECONDARY Weighted Mean Heart Rate (0-4 Hour) (AUEC, HR) |
61.4; 60.9 | — |
| SECONDARY Maximum Observed QTcF (Emax, QTcF) After Dosing of Salbutamol |
408.7; 405.5 | — |
| SECONDARY Weighted Mean QTcF (0-4 Hour) (AUEC, QTcF) |
384.6; 380.8 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
9; 7; 0; 0 | — |
| SECONDARY Absolute Values of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and Corrected QT (QTc) Interval |
160.5; 157.1; 149.2; 150.2; 149.8; 153.2 | — |
| SECONDARY Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval and QTc Interval |
160.5; 157.1; -11.3; -6.9; -10.7; -3.9 | — |
| SECONDARY Absolute Values of ECG Parameter: Heart Rate |
59.9; 63.2; 71.6; 73.3; 71.9; 70.5 | — |
| SECONDARY Change From Baseline in ECG Parameters: Heart Rate |
59.9; 63.2; 11.7; 10.1; 12.0; 7.3 | — |
| SECONDARY Absolute Values of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Count |
0.03; 0.02; 0.01; 0.00; 0.16; 0.15 | — |
| SECONDARY Absolute Values of Hematology Parameter: Red Blood Cell (RBC) and Reticulocytes Count |
4.889; 5.074; 4.703; 4.590; 0.064; 0.074 | — |
| SECONDARY Absolute Values of Hematology Parameter: Mean Corpuscular Volume (MCV) |
85.07; 86.14; 86.50; 85.38 | — |
| SECONDARY Absolute Values of Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) |
29.453; 29.832; 30.063; 29.288 | — |
| SECONDARY Absolute Values of Hematology Parameter: Hemoglobin |
143.87; 150.79; 140.76; 134.35 | — |
| SECONDARY Absolute Values of Hematology Parameter: Hematocrit |
0.416; 0.436; 0.404; 0.392 | — |
| SECONDARY Absolute Values of Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatine Phosphokinase (CPK) |
24.21; 24.14; 26.36; 24.38; 69.57; 66.36 | — |
| SECONDARY Absolute Values of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine |
2.86; 3.57; 3.14; 2.46; 9.64; 11.43 | — |
| SECONDARY Absolute Values of Clinical Chemistry Parameter: Total Protein |
75.21; 73.93; 68.57; 68.00 | — |
| SECONDARY Absolute Values for Chemistry Parameters: Calcium, Sodium, Potassium, Blood Urea Nitrogen (BUN) |
2.535; 2.549; 2.466; 2.442; 140.07; 139.43 | — |
| SECONDARY Absolute Values for Chemistry Parameter: Glucose |
5.04; 4.89; 5.43; 5.02; 5.64; 5.14 | — |
| SECONDARY Number of Participants With Urinalysis Parameters by Dipstick Method |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Absolute Values of Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) |
69.1; 69.4; 68.2; 67.8; 70.6; 69.1 | — |
| SECONDARY Absolute Values of Pulse Rate |
58.6; 61.7; 70.8; 71.8; 69.4; 73.5 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 18 to 55 years, inclusive, at screening
- Body mass index 18.0 to 30.0 kilograms per meter square (kg/m^2), inclusive, at screening
- Weight: greater than or equal to (>=)50 kg
- At screening, females must not be pregnant or lactating, or of non-childbearing potential
- Female participants of childbearing potential who have a fertile male sexual partner must agree to use adequate contraception
- Male participants, if not surgically sterilized, must agree to use adequate contraception
- Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, electrocardiogram, and vital signs, as judged by the investigator
- Willing and able to sign the informed consent form
Exclusion Criteria
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data
- History or presence of any form of asthma, including childhood asthma and exercise induced asthma
- Current enrollment or past participation in this clinical study
- Participants with clinically significant abnormalities
- A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse
- Positive nasopharyngeal polymerase chain reaction test for severe acute respiratory syndrome-corona virus type 2 (SARS-CoV-2) on Day -1 or any known close contact with a person who tested positive for SARS-CoV-2 or with a coronavirus disease 2019 participant within 2 weeks prior to admission
- Impairment which would prevent the correct and consistent use of an MDI, as determined by the investigator
Data sourced from ClinicalTrials.gov (NCT05791565). 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.