Relative Bioavailability Study in Healthy Subjects (PDF112034)

June 23, 2017 updated by: GlaxoSmithKline

A Two Part Single Dose, Randomized, Balanced, Crossover Study to Assess the Relative Bioavailability of Three Formulations, Drug Interaction and Food Effect on an GSK1322322 in Healthy Subjects

Part 1 of this study will assess the relative bioavailability of GSK1322322 administered as one of three investigational tablets compared to powder in a bottle formulation. Pharmacokinetics of these three tablets will be evaluated and the investigation tablet with the optimal PK profile will be progressed to Part 2. In Part 2 the investigational tablet selected from Part 1 will be coadministered with food alone, an H2 blocker alone, or an H2 blocker given in combination with ascorbic acid to evaluate the effect on GSK1322322 pharmacokinetics. Plasma GSK1322322 PK profile, safety, and tolerability will be assessed from each dose group.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

    • New York
      • Buffalo, New York, United States, 14202
        • 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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject is healthy.
  • Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
  • A female is eligible to enter and participate in this study if she is of Non-childbearing potential
  • Male subjects must agree to use one of the contraception methods listed in the protocol Body weight greater than or equal to 50 kg and body mass index between 18.5-29.9 kg/m2 inclusive.

Capable of giving written informed consent

  • QTcB less than 450 msec; or QTc less than 480 msec in subjects with Bundle Branch Block on Screening ECG.
  • AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated bilirubin greater than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%)

Exclusion Criteria:

  • The subject has a positive pre-study drug/alcohol screen.
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A positive test for HIV antibody.
  • History of regular alcohol consumption within 6 months of the study defined in the protocol.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than four new chemical entities within 12 months prior to the dosing day.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • Pregnant females as determined by positive human chorionic gonadotropin test at screening or prior to dosing.
  • Lactating females.
  • Subjects who have asthma or a history of asthma within the past 6 months.
  • History of smoking or history of regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
  • Consumption of red wine, seville oranges, grapefruit or grapefruit juice, pummelos, satsuma, ugli, tangerine, and tangelo, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Part 1
A 4 way crossover of three GSK1322322 tablet formulations and GSK1322322 powder in bottle
Four different formulations of 1000mg of GSK1322322
GSK1322322 1000mg
EXPERIMENTAL: Part 2
A 3 way crossover of a GSK1322322 tablet with a high fat meal, with Ranitidine, and with Ranitidine and Vitamin C.
Four different formulations of 1000mg of GSK1322322
GSK1322322 1000mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
GSK1322322 Blood PK as described in the protocol
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety parameters including adverse events, clinical laboratory tests, concomitant medications, electrocardiograms, and vital signs.
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 27, 2009

Primary Completion (ACTUAL)

July 9, 2009

Study Completion (ACTUAL)

July 9, 2009

Study Registration Dates

First Submitted

June 18, 2009

First Submitted That Met QC Criteria

June 18, 2009

First Posted (ESTIMATE)

June 19, 2009

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 23, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Informed Consent Form
    Information identifier: 112034
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: 112034
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: 112034
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: 112034
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Study Protocol
    Information identifier: 112034
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: 112034
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: 112034
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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