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

NCT01563042 | Completed Phase 1

• 1 other identifier: 114594
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

immunogenicity; GSK2434735; pharmacokinetics (PK); PK; biospecific antibody

Outcome Measures

Primary Outcomes (1)

• Profile of Pharmacokinetics

  Cmax, tmax, AUC, CL, t1/2

  42 days

Secondary Outcomes (5)

• Safety and tolerability of GSK2434735 as assessed by telemetry and change from baseline in 12-lead Electrocardiograms (ECG)

  42 days

• Safety and tolerability of GSK2434735 as assessed by change from baseline in blood pressure and heart rate

  42 days

• Safety and tolerability of GSK2434735 as assessed by number of participants with adverse events

  42 days

• Change from baseline for Clinical laboratory assessments (hematology, chemistry and urinalysis

  42 days

• Assessment of human anti-drug antibodies (ADA) in blood

  42 days

Study Arms (2)

Cohort 1 GSK2434735

EXPERIMENTAL

Cohort 1: Single intravenous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose.

Drug: Intravenous (IV) single dose

Cohort 2 GSK2434735

EXPERIMENTAL

Cohort 2: Single subcutaneous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose.

Drug: Subcutaneous (SC) single dose

Interventions

Intravenous (IV) single dose DRUG

GSK2434735 administered as a single intervenous dose at the beginning of the study

Also known as: GSK2434735

Cohort 1 GSK2434735

Subcutaneous (SC) single dose DRUG

GSK2434735 administered as a single subcutaneous dose at the beginning of the study

Also known as: GSK2434735

Cohort 2 GSK2434735

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 114594 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Asthma

Interventions

Injections, Subcutaneous

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 26, 2012
• Study Start: February 13, 2012
• Primary Completion: May 23, 2012
• Study Completion: May 23, 2012
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)