Last updated: 01/25/2021 17:30:06

Succinate Salt Version of GSK961081 for Healthy Volunteers

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GSK study ID
MAB108115
See study documents
Clinicaltrials.gov ID
NCT00550225
EudraCT ID
2007-004441-15
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomised, double-blind, dose escalating study in healthy volunteers to assess the safety, tolerability, extra pulmonary pharmacodynamics and pharmacokinetics of single doses of GSK961081 (succinate salt)
Trial description: Salt Bridging study for GSK961081
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

FEV1 at intervals

Timeframe: during the 10 week study

Cardiac monitoring at intervals

Timeframe: during the 10 week study

Secondary outcomes:

Plasma concentrations of GSK961081 at intervals

Timeframe: during the 10 week study

PK parameters at intervals

Timeframe: during the 10week study

Interventions:
Drug: GSK961081
Drug: GSK961081 matching placebo
Enrollment:
18
Observational study model:
Not applicable
Primary completion date:
2008-08-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
batefenterol
Collaborators
Not applicable
Study date(s)
November 2007 to January 2008
Type
Interventional
Phase
1

Participation criteria

Sex
Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
  • Healthy adult males or female aged between 18 and 50 years.
  • Body mass index within the range 19-29.9 kilograms/metre2
  • Who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
  • History of respiratory disease
Inclusion and exclusion criteria
Inclusion criteria:
  • Healthy adult males or female aged between 18 and 50 years.
  • Body mass index within the range 19-29.9 kilograms/metre2
  • Forced Expiratory Volume in 1 second (FEV1) >80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio > 0.7
  • Subjects 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 < 10 pack years.
Exclusion criteria:
  • Who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
  • History of respiratory disease
  • Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening >450msec on an individual ECG or a PR interval outside the range 120-210 msec
  • Supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
  • Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study
  • Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort.
  • Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 3 months
  • Infected with the Hepatitis B, Hepatitis C, or HIV virus
  • Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation

Trial location(s)

Location
Status
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Location
GSK Investigational Site
London, United Kingdom, NW10 7NS
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
2008-08-01
Actual study completion date
2008-08-01

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
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Results for study MAB108115 can be found on the GSK Clinical Study Register.
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