We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

First Time in Human Study Using GSK2330672

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01416324
First Posted: August 15, 2011
Last Update Posted: June 20, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The purpose of this study is to look at the safety and tolerability of increasing single doses of GSK2330672 in healthy volunteers.

Condition Intervention Phase
Diabetes Mellitus, Type 2 Drug: placebo 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 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Actual Study Start Date: June 15, 2011
Study Completion Date: September 9, 2011
Primary Completion Date: September 9, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK2330672
experimental study drug
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.
Placebo Comparator: Placebo
placebo
Drug: placebo
Vehicle used to dilute the powder for oral administration.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416324


Locations
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 114985
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 114985
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 114985
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 114985
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 114985
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 114985
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 114985
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01416324     History of Changes
Other Study ID Numbers: 114985
First Submitted: June 16, 2011
First Posted: August 15, 2011
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by GlaxoSmithKline:
pharmacodynamics
first time in human
pharmacokinetics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases