Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma (NCT04673630) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma
Hungary, South Africa, United Kingdom18 participantsStarted 2021-02-23
Plain-language summary
This study will evaluate the pharmacokinetic (PK) profile of a single subcutaneous (SC) dose of tezepelumab in children aged ≥ 5 to 11 years with asthma.
Who can participate
Age range5 Years – 11 Years
SexALL
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Inclusion Criteria:
* Written informed consent and written informed assent and any locally required authorisation obtained from the subject and legal representative prior to any study related procedure taking place.
* Age 5 to 11 years (inclusive) at Visit 1 and Visit 2 (Day 1). Type of Subject and Disease Characteristics
* Documented physician diagnosed asthma for at least 6 months prior to Visit 1.
* Documented treatment with total daily dose of either low, medium, or high dose ICS for at least 6 months, as described in Step 2 to Step 4 of GINA guidelines (GINA 2020) with stable dose for at least 3 months prior to Visit 1.
* Pre bronchodilator (BD) FEV1 of ≥ 50% of predicted normal value at Visit 1
* Body weight ≥ 16 kg at Visit 1 and Visit 2 (Day 1).
Exclusion Criteria:
* History of any clinically significant disease or disorder other than asthma which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* History of a deterioration in asthma or asthma exacerbation that required a burst of systemic corticosteroids within 6 weeks of Visit 1, up to and including Visit 2 (Day 1).
* History of hospitalisation (overnight admission) for asthma within 3 months of Visit 1, up to and including Visit 2 (Day 1).
* History of a life threatening asthma exacerbation requiring intubation or mechanical ventilation.
* History of systemic corticosteroid…
What they're measuring
1
Maximum Observed Serum Concentration (Cmax) of Tezepelumab
Timeframe: Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85
2
Time to Achieve Maximum Observed Serum Concentration (Tmax) of Tezepelumab
Timeframe: Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85
3
Area Under the Concentration-Time Curve From Time Zero to The Last Measurable Concentration (AUC0-last) of Tezepelumab
Timeframe: Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85
4
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tezepelumab
Timeframe: Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85
5
Terminal Phase Elimination Half-Life (t1/2) of Tezepelumab
Timeframe: Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85
6
Apparent Clearance (CL/F) of Tezepelumab
Timeframe: Predose and within ± 1 hour of postdose on Day 1; on Days 3, 7, 11, 15, 29, 57 and 85
7
Apparent Steady-State Volume of Distribution (Vss/F) of Tezepelumab