Study to Assess the Pharmacokinetics of GSK1278863A Coadministered With a High Fat Meal or an Inhibitor of CYP2C8 (Gemfibrozil)

NCT01376232 | Completed Phase 1

• 1 other identifier: 113634
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Study to Assess the Pharmacokinetics of GSK1278863A Coadministered with a High Fat Meal or an Inhibitor of CYP2C8 (gemfibrozil),\]

Conditions

Anaemia

Keywords

Anaemia; Drug- Drug Interaction

Outcome Measures

Primary Outcomes (1)

• GSK1278863A (and metabolites, as appropriate) AUC(0-¥) and Cmax

  1\. To assess the relative bioavailability GSK1278863A following single-dose administration under fasting and fed (standard high fat/calorie meal) conditions

  48 hours

Secondary Outcomes (2)

• 1. Plasma GSK1278863A (and metabolites, as appropriate) AUC(0-t), tmax, and t1/2.

  48hr

• Adverse event, clinical laboratory, ECG, vital signs, and concurrent medication assessments.

  48 hours and duration of study

Study Arms (3)

GSK1278863

EXPERIMENTAL

100 mg of GSK1278863

Drug: GSK1278863

GSK1278863 + food

EXPERIMENTAL

100 mg of GSK1278863 given with a high fat meal

Drug: GSK1278863 + food

GSK1278863 + Gemfibrozil

EXPERIMENTAL

GSK1278863A 100mg + Gemfibrozil 600mg steady state

Drug: Gemfibrozil

Interventions

GSK1278863 DRUG

GSk1278863 100mg

GSK1278863

GSK1278863 + food DRUG

High Fat meal + 100 mg GSK1278863

GSK1278863 + food

Gemfibrozil DRUG

600 mg Gemfibrozil

GSK1278863 + Gemfibrozil

Eligibility Criteria

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

You may qualify if:

• AST, ALT, alkaline phosphatase and bilirubin \> 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
• Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
• Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent
• A female subject is eligible to participate if she is of:Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<140 pmol/L) is confirmatory\]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks should elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method
• Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 5 terminal half-lives post-last dose
• Body weight \< 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive)
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
• QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block

You may not qualify if:

• 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)
• The values of hematological parameters at screening are: Any values outside the reference range
• A positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines
• The values of the following tests at screening are: Serum ferritin: outside the reference range
• A positive test for HIV antibody
• Clinically significant CPK \>3 X ULN or deemed clinically significant by the investigator
• Calculated creatinine clearance: \< 80 mL/min
• Subjects with a pre-exisisting condition interfering with normal gastrointestinal anatomy or motility, and/or hepatic function-that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Examples of conditions that could interfere with normal gastriointestinal anatomy or motility include cholecystectomy, vagotomy, malabsorption, Crohn's disease, ulcerative colitis, or celiac sprue
• History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 12 weeks, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
• History of peptic ulcer disease
• History of malignancy tumor. Non-melanoma skin cancer that has been definitely removed is allowed
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days 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

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Octagon Research Solutions, Incoporated: collaborator

Study Sites (1)

GSK Investigational Site

Electronics City, Bengalore, 560100, India

Location

Related Links

• Results for study 113634 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Anemia

Interventions

GSK1278863; Food; Gemfibrozil

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Pentanoic Acids; Valerates; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 20, 2011
• Study Start: November 8, 2010
• Primary Completion: December 20, 2010
• Study Completion: December 20, 2010
• Last Updated: June 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)