First Time in Human Study Using GSK2330672

June 19, 2017 updated by: GlaxoSmithKline

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

The purpose of this study is to look at the safety and tolerability of increasing single doses of GSK2330672 in healthy volunteers.

Study Overview

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Intervention / Treatment

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

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Minnesota
  - Minneapolis, Minnesota, United States, 55404
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo placebo	Drug: placebo Vehicle used to dilute the powder for oral administration.
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.

Participant Group / Arm

Intervention / Treatment

Placebo Comparator: Placebo

placebo

Drug: placebo

Vehicle used to dilute the powder for oral administration.

Experimental: GSK2330672

experimental study drug

Drug: 0.1 mg GSK2330672