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A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK1278863A in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00750256
First received: September 9, 2008
Last updated: March 15, 2012
Last verified: February 2011
  Purpose

A first-time in human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1278863A in healthy subjects


Condition Intervention Phase
Anemia
Anaemia
Drug: GSK1278863A
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of GSK1278863A in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • GSK1278863A safety endpoints: adverse events reporting, clinical safety laboratory tests (hematology, chemistry, urinalysis,and fecal occult blood), vital signs, 12-lead ECG, dual-lead cardiac monitoring. [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood and urine levels of GSK1278863A [ Time Frame: 2 Days ] [ Designated as safety issue: No ]
  • Effect of GSK1278863A on hematological markers [ Time Frame: 2 Days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: July 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohorts
This study will be a single-blind, randomized, placebo-controlled, dose-rising, single dose, parallel group study with 6 proposed Cohorts from 2mg to 450mg.
Drug: GSK1278863A
GSK1278863A planned doses from 2mg to 450mg which may change based on safety or PK from previous cohorts.
Other Name: GSK1278863A

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, non-smoking (within 40 days of screening), adult males and females between 18 and 55 years of age, inclusive
  • Female subjects are eligible for participation in the study if they are of:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant);
  • Male subjects agree to use contraception methods
  • Body weight > or = 50 kg; BMI: 19-31 kg/m2, inclusive
  • Subject has a QTc <450 msec or <480 msec if associated with bundle branch block
  • Subject is willing and able to provide written informed consent

Exclusion Criteria:

  • MCV value outside the reference range at screening
  • Hemoglobin value at screening is: male subjects or post-menopausal females > 15.5 g/dL; female subjects > 14.5 g/dL
  • TIBC, serum iron and serum ferritin values are outside the reference range at screening
  • Calculated creatinine clearance < 60 ml/min
  • Clinically significant abnormal CPK determined by the investigator and medical monitor
  • AST, ALT and direct bilirubin are greater than upper limit of reference range at screening
  • Subjects are unwilling or inability to follow the procedures and lifestyle and/or dietary restrictions outlined in the protocol
  • Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor this will not interfere with the study procedures or compromise subject safety
  • Subject currently exposures to more than four new chemical entities within 12 months prior to the first dosing day
  • Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days prior to the first dose of study medication
  • Subject has a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy
  • Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs.
  • Subject has a history of GI ulceration or gastrointestinal bleeding
  • Subject has a history of peptic ulcer disease
  • Subject has a history of malignancy tumor; non-melanoma skin cancer that has been definitely removed is allowed
  • Treatment with an investigational drug within 30 days preceding the first dose of study medication
  • Subjects with a history of drug abuse
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening
  • Positive urine drug screen (UDS) at screening
  • Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result or positive HIV result within 3 months of screening
  • Donation of blood in excess of 500 mL within 56 days prior to first dose of study medication
  • Subject has a history of regular use of tobacco- or nicotine containing products
  • History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof
  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: NCT00750256

Locations
United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00750256     History of Changes
Other Study ID Numbers: PHX111427
Study First Received: September 9, 2008
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Safety
pharmacokinetics
tolerability

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014