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

NCT00750256 | Completed Phase 1

• 1 other identifier: PHX111427
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anaemia

Keywords

tolerability; Safety; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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.

  1 Day

Secondary Outcomes (2)

• Blood and urine levels of GSK1278863A

  2 Days

• Effect of GSK1278863A on hematological markers

  2 Days

Study Arms (1)

Cohorts

EXPERIMENTAL

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

Interventions

GSK1278863A DRUG

GSK1278863A planned doses from 2mg to 450mg which may change based on safety or PK from previous cohorts.

Cohorts

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Evansville, Indiana, 47710, United States

Location

Related Links

• Results for study PHX111427 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2008
• First Posted: September 10, 2008
• Study Start: July 7, 2008
• Primary Completion: December 12, 2008
• Study Completion: December 12, 2008
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)