First Time in Human Study Using GSK2330672
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): placebo; 0.1 mg GSK2330672; 0.3 mg GSK2330672; 1 mg GSK2330672; 3 mg GSK2330672; 10 mg GSK2330672; 30 mg GSK2330672; 60 mg GSK2330672
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Vehicle used to dilute the powder for oral administration.; GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.; GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.; GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.; GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.; GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.; GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.; GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: pharmacodynamics; first time in human; pharmacokinetics