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First Time in Human Study Using GSK2330672

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01416324
First received: June 16, 2011
Last updated: March 8, 2012
Last verified: October 2011
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in vital signs [ Time Frame: 1, 2, 4, 8, 12, 24, 48 hours ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    frequency of clinically significant changes in 12-lead ECG parameters relative to placebo

  • Changes in clinical lab results [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Changes in clinical chemistry, hematology, urinalysis results relative to placebo

  • lung function tests [ Time Frame: 1, 3, 8, 24 hours ] [ Designated as safety issue: Yes ]
    Measure changes in FEV, FVC, FEF 25-75%, PEFR relative to placebo

  • Adverse events relative to placebo [ Time Frame: 48 hour monitoring ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK2330672
experimental study drug
 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
 Drug: placebo

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01416324     History of Changes
Other Study ID Numbers: 114985
Study First Received: June 16, 2011
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013