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First Time in Human Study Using GSK2330672

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01416324
Recruitment Status : Completed
First Posted : August 15, 2011
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE June 16, 2011
First Posted Date  ICMJE August 15, 2011
Last Update Posted Date June 20, 2017
Actual Study Start Date  ICMJE June 15, 2011
Actual Primary Completion Date September 9, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2011)
  • Change in vital signs [ Time Frame: 1, 2, 4, 8, 12, 24, 48 hours ]
    frequency and absolute value change in heart rate, blood pressure, respiration rate relative to placebo
  • ECGs relative to placebo [ Time Frame: 1, 2, 4, 8, 12, 24, 48 hours ]
    frequency of clinically significant changes in 12-lead ECG parameters relative to placebo
  • Changes in clinical lab results [ Time Frame: 24 hours ]
    Changes in clinical chemistry, hematology, urinalysis results relative to placebo
  • lung function tests [ Time Frame: 1, 3, 8, 24 hours ]
    Measure changes in FEV, FVC, FEF 25-75%, PEFR relative to placebo
  • Adverse events relative to placebo [ Time Frame: 48 hour monitoring ]
    Frequency and severity of adverse events relative to placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2011)
  • Measurement of the maximum concentration (Cmax) for study drug [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours ]
  • Measurement of the time to achieve maximum concentration (tmax) for study drug [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours ]
  • Measurement of area under the curve (AUC) for study drug [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours ]
  • Measurement of half life (t 1/2) of study drug [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours ]
  • Measurement of apparent clearance (CL/F) of the study drug [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours ]
  • Measurement of the apparent volume of distribution (V/F) of the study drug [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3.5, 5, 6.5, 8, 9.5, 12.5 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First Time in Human Study Using GSK2330672
Official Title  ICMJE A First Time in Human, Single Blind, Randomized, Placebo-controlled,Dose Escalating Crossover Study to Evaluate the Safety,Tolerability, Pharmacokinetic and Pharmacodynamic Parameters of Single Doses of GSK2330672 in Healthy Volunteers
Brief Summary The purpose of this study is to look at the safety and tolerability of increasing single doses of GSK2330672 in healthy volunteers.
Detailed Description

This is a single blind, randomized, placebo-controlled, dose escalating, crossover, first time in human study to examine safety, tolerability, pharmacokinetic and pharmacodynamic parameters of GSK233672. Single blind indicates that the subjects and investigator are blinded to treatment but the GSK study team could be unblinded for ongoing review of interim safety data required for dose escalation.

Subjects will participate in 4 dosing periods. Subjects will enter the clinic prior to dinner time on the evening of Day -1 of each period and will remain in residence through the morning of Day 3. Barring any safety or tolerability concerns, subjects will be released at this time provided they have had at least 1 bowel movement after dosing in the clinic.

Subjects will return for their next scheduled dosing period. This process will be repeated for each dosing period. Subjects will return approximately 1 week after check out from their last dosing period for a follow up visit. Subjects will receive standardized meals meeting specific criteria starting with dinner on Day-1 and continuing through Day 1. Standard meals will be provided for the remainder of their stay in the clinic. After an overnight fast, subjects will take their study drug on the morning of Day 1. Dosing will be followed by breakfast and frequent blood sampling to assess pharmacokinetic and pharmacodynamic parameters. Scheduled assessments of heart rate, blood pressure, respiratory rate, ECGs, and clinical laboratories will be obtained to monitor subject safety. Subjects will be connected to cardiac telemetry monitors and will periodically undergo spirometry testing of ventilation parameters. Stool form and frequency of bowel movements will be recorded. All fecal samples will be collected from participants for 48 hours after dosing of study drug, or until they have had at least 1 bowel movement after dosing, whichever occurs first.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: placebo
    Vehicle used to dilute the powder for oral administration.
  • Drug: 0.1 mg GSK2330672
    GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
  • Drug: 0.3 mg GSK2330672
    GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
  • Drug: 1 mg GSK2330672
    GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
  • Drug: 3 mg GSK2330672
    GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
  • Drug: 10 mg GSK2330672
    GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
  • Drug: 30 mg GSK2330672
    GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
  • Drug: 60 mg GSK2330672
    GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
Study Arms  ICMJE
  • Experimental: GSK2330672
    experimental study drug
    Interventions:
    • Drug: 0.1 mg GSK2330672
    • Drug: 0.3 mg GSK2330672
    • Drug: 1 mg GSK2330672
    • Drug: 3 mg GSK2330672
    • Drug: 10 mg GSK2330672
    • Drug: 30 mg GSK2330672
    • Drug: 60 mg GSK2330672
  • Placebo Comparator: Placebo
    placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2011)
17
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 9, 2011
Actual Primary Completion Date September 9, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy volunteer
  • 18-60 yrs of age
  • for subjects age 50 and above: negative fecal occult blood test within 3 months prior to expected start of dosing, and normal results from sigmoidoscopy or colonoscopy within 5 yrs prior to dosing.
  • if female, must be of non-childbearing potential

Exclusion Criteria:

  • pregnant or breastfeeding females
  • positive HIV
  • positive Hep B, or Hep C within 3 months of screening
  • positive drugs of abuse screening
  • triglycerides > 250 mg/dL
  • current or chronic history of liver disease
  • any gastrointestinal or gastrointestinal related conditions that could affect fat or bile acid reabsorption
  • pancreatitis
  • colon cancer or 1st degree relative who has had colon cancer
  • abnormal lung function tests
  • inability to perform lung function tests
  • unwilling to abstain from smoking, alcohol, caffeine, illicit drugs as directed by the site staff
  • exposure to more than 4 new chemical entities in the 12 months prior to the first dosing day.
  • where participation in the study would results in donation of more than approximately 550mL of blood in a 56-day period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01416324
Other Study ID Numbers  ICMJE 114985
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2017

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