First Time in Human Study Using GSK2330672

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT01416324

Collaborator

(none)

Enrollment

Location

Arms

2.8

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	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

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 Design

Study Type:

Interventional

Actual Enrollment :

17 participants

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

Actual Study Start Date :

Jun 15, 2011

Actual Primary Completion Date :

Sep 9, 2011

Actual Study Completion Date :

Sep 9, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

Experimental: GSK2330672

experimental study drug

Drug: 0.1 mg GSK2330672