Relative Bioavailability Study in Healthy Subjects (PDF112034)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00924911
First received: June 18, 2009
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Skin Diseases, Infectious
Pneumonia
Infections, Bacterial
Drug: GSK1322322
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • GSK1322322 Blood PK as described in the protocol [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety parameters including adverse events, clinical laboratory tests, concomitant medications, electrocardiograms, and vital signs. [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: April 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1
A 4 way crossover of three GSK1322322 tablet formulations and GSK1322322 powder in bottle
Drug: GSK1322322
Four different formulations of 1000mg of GSK1322322
Experimental: Part 2
A 3 way crossover of a GSK1322322 tablet with a high fat meal, with Ranitidine, and with Ranitidine and Vitamin C.
Drug: GSK1322322
GSK1322322 1000mg

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924911

Locations
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14202
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00924911     History of Changes
Other Study ID Numbers: 112034
Study First Received: June 18, 2009
Last Updated: January 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GSK1322322, relative bioavailability, single dose, food effect, H2 blocker, healthy subjects, open label, PIB, tablet

Additional relevant MeSH terms:
Skin Diseases
Bacterial Infections
Communicable Diseases
Infection
Skin Diseases, Infectious

ClinicalTrials.gov processed this record on September 22, 2014