Asthma
Conditions
Keywords
Pediatric asthma
Brief summary
The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.
Interventions
Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
DRUGMAP0010 low dose
Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
DRUGMAP0010 intermediate dose
Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Sponsors
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Q-Pharm Pty Limited
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult volunteers, aged 18-50 years * BMI less than 30 kg/m2 * Non smoker (currently and \<10 pack years total if ex-smoker)
Exclusion criteria
* Any use of corticosteroid in previous 4 weeks * Pregnancy/lactation * Significant blood donation (or testing) in previous 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010 | 8 hours | The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml). |
| Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 8 hours | Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min). |
| AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010 | 8 hours | The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg\*min/ml). |
| AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 8 hours | The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg\*min/ml). |
| Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 8 hours | Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes (min). |
Countries
Australia
Participant flow
Pre-assignment details
All subjects received all 4 treatments in a randomly assigned order. The treatments were: Treatment A: Pulmicort Respules® Treatment B: MAP0010 low dose Treatment C: MAP0010 intermediate dose Treatment D: MAP0010 high dose The sequences were Treatments ABDC, BACD, CDBA, DACB.
Participants by arm
| Arm | Count |
|---|---|
| All Patients All patients that were enrolled in the study. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 23.3 years STANDARD_DEVIATION 4.3 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 16 | 4 / 16 | 3 / 16 | 3 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
Primary
AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010
The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg\*min/ml).
Time frame: 8 hours
Population: Patients with available data at specified time points are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A | AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010 | 29040 pg*min/mL | Standard Deviation 9316 |
| Treatment B | AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010 | 3978 pg*min/mL | Standard Deviation 1974 |
| Treatment C | AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010 | 8626 pg*min/mL | Standard Deviation 4184 |
| Treatment D | AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010 | 22130 pg*min/mL | Standard Deviation 9675 |
Primary
AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg\*min/ml).
Time frame: 8 hours
Population: Patients with available data at specified time points are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A | AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 31480 pg*min/mL | Standard Deviation 10690 |
| Treatment B | AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 4391 pg*min/mL | Standard Deviation 1423 |
| Treatment C | AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 7842 pg*min/mL | Standard Deviation 3647 |
| Treatment D | AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 25290 pg*min/mL | Standard Deviation 11750 |
Primary
Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010
The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).
Time frame: 8 hours
Population: Patients with available data at specified time points are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A | Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010 | 303.5 pg/mL | Standard Deviation 177.4 |
| Treatment B | Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010 | 106.2 pg/mL | Standard Deviation 63.47 |
| Treatment C | Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010 | 239.9 pg/mL | Standard Deviation 140.1 |
| Treatment D | Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010 | 434.5 pg/mL | Standard Deviation 246.9 |
Primary
Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes (min).
Time frame: 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A | Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 145.4 min | Standard Deviation 40.84 |
| Treatment B | Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 73.02 min | Standard Deviation 33.43 |
| Treatment C | Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 78.35 min | Standard Deviation 27.08 |
| Treatment D | Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 140.0 min | Standard Deviation 54.19 |
Primary
Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).
Time frame: 8 hours
Population: Patients with available data at specified time points are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A | Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 9.063 min | Standard Deviation 7.122 |
| Treatment B | Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 4.467 min | Standard Deviation 3.27 |
| Treatment C | Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 3.125 min | Standard Deviation 1.5 |
| Treatment D | Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010 | 3.688 min | Standard Deviation 1.448 |