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
Study complete
Study complete
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
    Primary completion date:
    2008-08-01
    Observational study model:
    Not applicable
    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
    • Inclusion Criteria:
    • Healthy adult males or female aged between 18 and 50 years.
    Inclusion and exclusion criteria
    Inclusion 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
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, NW10 7NS
    Status
    Study Complete
    Contact us

    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
    Study complete
    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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