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A Single Dose Pharmacokinetics (PK) Study of GSK2434735 in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01563042
First received: March 15, 2012
Last updated: May 31, 2012
Last verified: May 2012

March 15, 2012
May 31, 2012
February 2012
May 2012   (final data collection date for primary outcome measure)
Profile of Pharmacokinetics [ Time Frame: 42 days ] [ Designated as safety issue: No ]
Cmax, tmax, AUC, CL, t1/2
Same as current
Complete list of historical versions of study NCT01563042 on ClinicalTrials.gov Archive Site
  • Safety and tolerability of GSK2434735 as assessed by telemetry and change from baseline in 12-lead Electrocardiograms (ECG) [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Change from baseline for PR, RR, QRS, QT, QTc measurements at Day 42
  • Safety and tolerability of GSK2434735 as assessed by change from baseline in blood pressure and heart rate [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Change from baseline for systolic and diastolic blood pressure and heart rate measurements at 42 Days
  • Safety and tolerability of GSK2434735 as assessed by number of participants with adverse events [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Clinically relevant changes from baseline in subject's disposition at Day 42
  • Change from baseline for Clinical laboratory assessments (hematology, chemistry and urinalysis [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Changes from baseline values of hematologic , chemistry and urinary testing parameters at Day 42
  • Assessment of human anti-drug antibodies (ADA) in blood [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Incidence of human anti-drug antibodies (ADA) at Day 42
Same as current
Not Provided
Not Provided
 
A Single Dose Pharmacokinetics (PK) Study of GSK2434735 in Healthy Male Volunteers
An Exploratory First Time in Human (FTIH) Study Investigating the Pharmacokinetics (PK), Immunogenicity, Safety and Tolerability of GSK2434735 Administered as a Single Low Dose in Healthy Male Subjects

An exploratory First Time in Human (FTIH) study investigating the pharmacokinetics, immunogenicity, safety and tolerability of GSK2434735 administered as a single low dose in healthy male subjects

Interleukin-13 (IL-13) and IL-4 are mediators in the pathogenesis of established asthmatic disease. GSK2434735 is a bispecific antibody to IL-13 and IL-4. The purpose of this open label, sequential cohort, exploratory First Time in Human (FTIH) study is to evaluate the pharmacokinetics (PK) profile of GSK2434735 after a single low intravenous or subcutaneous dose in healthy male volunteers, and to assess if the pharmacokinetics (PK) parameters can be scaled from monkey to man. In addition, the safety and tolerability will be monitored and the study will assess if antibodies are generated to GSK2434735.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Asthma
  • Drug: Intravenous (IV) single dose
    GSK2434735 administered as a single intervenous dose at the beginning of the study
    Other Name: GSK2434735
  • Drug: Subcutaneous (SC) single dose
    GSK2434735 administered as a single subcutaneous dose at the beginning of the study
    Other Name: GSK2434735
  • Experimental: Cohort 1 GSK2434735
    Cohort 1: Single intravenous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose.
    Intervention: Drug: Intravenous (IV) single dose
  • Experimental: Cohort 2 GSK2434735
    Cohort 2: Single subcutaneous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose.
    Intervention: Drug: Subcutaneous (SC) single dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male volunteers between 18 and 65 years of age
  • Negative for pre-existing antibodies to GSK2434735.
  • Body weight greater than and equal to 50 kg
  • BMI 19 - 29.9 kg/m2.
  • Lifelong non-smokers or ex-smokers of greater than 6 months

Exclusion Criteria:

  • Clinically significant abnormalities.
  • Current or past history of significant cardiac, respiratory, metabolic, renal, hepatic, neurological or gastrointestinal conditions.
  • Current evidence or recent history of an infective illness.
  • Vaccination within 3 weeks of screening
  • History of severe allergic reactions, angio-oedema, anaphylaxis or immunodeficiency
Male
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01563042
114594
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2012

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