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A Phase 1, Open-label Study to Investigate the Pharmacokinetics of Tralokinumab (CAT-354) in Adolescents With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01592396
First received: April 25, 2012
Last updated: January 20, 2017
Last verified: January 2017
April 25, 2012
January 20, 2017
June 2012
January 2013   (Final data collection date for primary outcome measure)
  • Time to Reach Maximum Observed Serum Concentration (Tmax) [ Time Frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 ]
  • Maximum Observed Serum Concentration (Cmax) [ Time Frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 ]
  • Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity]) [ Time Frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 ]
    AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
  • Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t]) [ Time Frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 ]
  • Terminal Phase Elimination Half Life (t1/2) [ Time Frame: 0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57 ]
    Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.
  • Pharmacokinetics [ Time Frame: Day 1 - Day 57 ]
    Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation (AUC(0-infinity); AUC(0-t)); dose-normalized AUC(0-infinity) (AUC(0-infinity)/D);
  • Pharmacokinetics [ Time Frame: Day 1 - Day 57 ]
    Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation Cmax; dose-normalized Cmax (Cmax/D); time to Cmax (Tmax);
  • Pharmacokinetics [ Time Frame: Day 1 - Day 57 ]
    Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation dose-normalized terminal-phase elimination half-life (t1/2);
  • Pharmacokinetics [ Time Frame: Day 1 - Day 57 ]
    Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation apparent clearance (CL/F)
  • Pharmacokinetics [ Time Frame: Day 1 - Day 57 ]
    Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation steady-state volume of distribution (Vss/F).
Complete list of historical versions of study NCT01592396 on ClinicalTrials.gov Archive Site
  • Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 1 to Day 57 ]
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. Adverse events were summarized together for all participants.
  • Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit [ Time Frame: Day 1 and Day 57 ]
    Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. Immunogenicity results were summarized together for all participants.
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Day 1 - Day 57 ]
    To evaluate the saftey and tolerability of tralokinumab through monitoring of adverse event data from day 1 - day 57.
  • Safety and Tolerability through the measure of Immunogenicity [ Time Frame: Day 1 - Day 57 ]
    To evaluate the saftey and tolerability of tralokinumab through collection of immunogenicity samples to be tested for anti-drug antibodies
Not Provided
Not Provided
 
A Phase 1, Open-label Study to Investigate the Pharmacokinetics of Tralokinumab (CAT-354) in Adolescents With Asthma
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Tralokinumab in Adolescents With Asthma
The pharmacokinetic (PK) profile of tralokinumab (CAT‐354) will be studied in adolescent subjects with asthma.
Interleukin-13 (IL‐13) is a pleiotropic cytokine that promotes inflammation, airways hyper‐responsiveness (directly and through recruitment and activation of inflammatory cells), mucus hypersecretion, airway remodeling via fibrosis, increased immunoglobulin E (IgE) synthesis and mast cell activation.Tralokinumab (CAT‐354) is a human immunoglobulin G4 (IgG4) anti‐IL‐13 monoclonal antibody that has been shown to potently and specifically neutralize IL‐13 in preclinical models.This study will evaluate the PK profile of a single dose of tralokinumab administered subcutaneously at a dose of 300 mg in adolescent subjects with asthma to be compared with the PK data from completed studies in adults.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Asthma
Biological: Tralokinumab 300 mg
Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
Other Name: CAT-354
Experimental: Tralokinumab 300 mg
Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
Intervention: Biological: Tralokinumab 300 mg
Baverel PG, Jain M, Stelmach I, She D, Agoram B, Sandbach S, Piper E, Kuna P. Pharmacokinetics of tralokinumab in adolescents with asthma: implications for future dosing. Br J Clin Pharmacol. 2015 Dec;80(6):1337-49. doi: 10.1111/bcp.12725. Epub 2015 Oct 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 12-17 years (inclusive)
  • Weight greater than (>) 30 kilogram (kg)
  • Asthma for a minimum of 6 months prior to Screening
  • Effective birth control for both male and female participants in line with protocol details.
  • Exclusion Criteria:
  • Previously taken tralokinumab (the study drug)
  • Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals
  • Pregnant or breastfeeding women
  • Current smoker or cessation less than (<) 3 months prior to screening
  • Known immune deficiency excluding asymptomatic selective immunoglobulin A
  • History of cancer - Hepatitis B, C or human immunodeficiency virus (HIV) positive
  • Any disease which may cause complications whilst taking the study drug.
Sexes Eligible for Study: All
12 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT01592396
CD-RI-CAT-354-1054
2011-005503-33 ( EudraCT Number )
No
Not Provided
Not Provided
MedImmune LLC
MedImmune LLC
Not Provided
Study Director: Edward Piper, MBBS MedImmune Ltd
MedImmune LLC
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP