Study of GSK961081 in Healthy Volunteer Subjects
A Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetic Profile and Pharmacodynamics of Single and Repeat Inhaled Doses of GSK961081 in Healthy Subjects
1 other identifier
interventional
46
1 country
1
Brief Summary
GSK961081 is a new long-acting bronchodilator being developed for the treatment of chronic obstructive pulmonary disease (COPD). This study is the first clinical study in humans. The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK961081 in healthy male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2006
CompletedFirst Submitted
Initial submission to the registry
April 23, 2009
CompletedFirst Posted
Study publicly available on registry
April 24, 2009
CompletedOctober 6, 2021
September 1, 2021
11 months
April 23, 2009
September 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
General safety and tolerability (adverse events, clinical laboratory safety tests, cardiac monitoring, vital signs (including postural changes in blood pressure), 12-lead ECG parameters including QTc(b) and QTc(f), blood glucose and serum potassium).
Pre and post-dose on Days 1, 4 and 7
Secondary Outcomes (3)
Maxiumum and weighted mean (over 0-8 hours post-dose) for systolic and diastolic blood pressure, heart rate, QTc(F), QTc(B), plasma glucose and serum potassium
Days 1, 4 and 7
specific airway conductance (sGaW)
pre and post-dose on Days 1, 4 and 7
forced expiratory volume in one second (FEV1)
Pre and post-dose on Days 1, 4 and 7
Study Arms (10)
Cohort 1, Period 2
EXPERIMENTALGSK961081 3mcg, Placebo, GSK961081 15mcg, GSK961081 50mcg
Cohort 1, period 1
EXPERIMENTALPlacebo, GSK961081 3mcg, GSK961081 15mcg, GSK961081 50mcg
Cohort 1, period 3
EXPERIMENTALGSK961081 3mcg, GSK961081 15mcg, Placebo, GSK961081 50mcg
Cohort 1, period 4
EXPERIMENTALGSK961081 3mcg, GSK961081 15mcg, GSK961081 50mcg, Placebo
Cohort 2, period 1
EXPERIMENTALPlacebo, GSK961081 100mcg, GSK961081 200mcg, GSK961081 300mcg,
Cohort 2, period 2
EXPERIMENTALGSK961081 100mcg, Placebo, GSK961081 200mcg, GSK961081 300mcg
Cohort 2, period 3
EXPERIMENTALGSK961081 100mcg, GSK961081 200mcg, Placebo, GSK961081 300mcg
Cohort 2, period 4
EXPERIMENTALGSK961081 100mcg, GSK961081 200mcg, GSK961081 300mcg, Placebo
Cohort 3
EXPERIMENTALGSK961081 100mcg or Placebo
Cohort 4
EXPERIMENTALGSK961081 300mcg or Placebo
Interventions
Single dose delivered via solution for nebulisation
single dose delivered via nebulsier
single dose delivered via solution for nebulisation
single dose via nebuliser
single dose delivered via solution for nebulisation
single dose via nebuliser
single dose via nebuliser
Eligibility Criteria
You may qualify if:
- Healthy adult males aged between 18 and 50 years.
- Body mass index within the range 18.5-29.9 kilograms/meter2 (kg/m2).
- Forced Expiratory Volume in 1 second (FEV1) \<80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio \<0.7
- Response to Salbutamol defined as: an increase in sGAW of \>15% over pre-dose baseline within 2 h following administration of 400 mcg Salbutamol by MDI inhaler OR: a documented increase in sGAW of \>15% over pre-dose baseline within 2 h following administration of 400 mcg Salbutamol by MDI inhaler within 6 months of screening.
- Response to Ipratropium bromide defined as: an increase in sGaw of \>25% over pre-dose baseline within 2 h following 80 mcg Ipratropium bromide; OR: a documented increase in sGaw of \>25% over pre-dose baseline 2 h following administration of 80 mcg Ipratropium bromide within 6 months of screening.
- A signed and dated written informed consent is obtained for the subject
- The subject is able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions.
- Subjects who are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of \> or = 10 pack years.
- \[number of pack years = (number of cigarettes per day/20) x number of years smoked\]
You may not qualify if:
- Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead or Holter).
- A history of breathing problems (i.e. history of asthmatic symptoms). Screening lung function tests (FEV1, FVC and sGaw) will be performed to confirm normal lung function parameters.
- A mean QTc(B) and QTc(F) value at screening \>430msec, the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 120-210msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave).
- A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.
- A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
- The subject has donated a unit of blood within the 90 days or intends to donate within 90 days after completing the study.
- A history of claustrophobia such that they may not tolerate plethysmography measurements.
- The subject is currently taking regular (or course of) medication whether prescribed or not, including vitamins and herbal remedies such as St John's Wort.
- The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (which ever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sponsor the medication will not interfere with the study procedures or compromise subject safety.
- The subject has participated in a clinical study with another New Chemical Entity (NCE) within the past 112 days or a clinical study with any other drug during the previous 84 days.
- The subject is infected with the Hepatitis B, Hepatitis C, or HIV virus.
- The subject has a positive pre-study urine cotinine/ breath carbon monoxide test, urine drug/urine alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbituates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
- A history of regular alcohol consumption exceeding weekly intake of alcohol greater than 28 units, or an average daily intake of greater than 4 units.
- Are unable to use the Prodose AAD nebuliser device correctly.
- An unwillingness of subjects to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness of the subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or tubal ligation if the woman could become pregnant from the time of the first dose study medication until 90 days post-dose.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Theravance Biopharmalead
- GlaxoSmithKlinecollaborator
Study Sites (1)
GSK Investigational Site
London, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2009
First Posted
April 24, 2009
Study Start
November 7, 2005
Primary Completion
October 4, 2006
Study Completion
October 4, 2006
Last Updated
October 6, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.