Status:
COMPLETED
Bioavailability and Food Effect of the Original Gelatin Formulation and Two New Formulations of Afuresertib in Normal Healthy Volunteers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Cancer
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
This will be a randomized, open-label, sequential, single dose, 4-period crossover study. This study is being conducted to measure the relative bioavailability of the original gelatin capsule (GC) for...
Eligibility Criteria
Inclusion
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 40 years of age inclusive, at the time of signing the informed consent
- Body weight \>=50 kilograms (kg) and body mass index (BMI) \<=32 kg/m\^2 (square meter)
- A female subject is eligible to participate if she is of: (A) Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy or postmenopausal defined as 12 months of spontaneous amenorrhea (B) Child-bearing potential with negative pregnancy test as determined by serum human chorionic gonadotropin (hCG) test at Screening and prior to dosing, AND: agrees to use one of the acceptable contraception methods
- Male subjects with female partners of child-bearing potential must agree to use one of the acceptable contraception methods.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin \<=1.5 x Upper Limit of Normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
- Based on single or averaged corrected QT interval (QTc) values of triplicate electrocardiograms (ECGs) obtained over a brief recording period: QTc \<450 milliseconds (msec) or QTc \<480 msec in subjects with Bundle Branch Block
Exclusion
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of gastroesophageal reflux disease (GERD), dyspepsia, gastrointestinal (GI) bleeding, GI surgery that could affect motility
- History of atrial arrhythmias
- 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 grams (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- 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
- Use of prescription or non-prescription medications, vitamins, and dietary or herbal supplements (including St John's Wort) within 7 days (or 14 days if the drug/supplement is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study drug until completion of the Follow-up Period, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study
- Unable to abstain from smoking tobacco or the use of nicotine-containing products while admitted to the clinic
- 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 Drug on Day 1 of Dosing Period 1, until completion of the Follow-up Period
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Screening
- History of heavy use of tobacco- or nicotine-containing products within 6 months prior to Screening.
- A positive drug/alcohol screen at Screening or upon check-in to the clinic on Day -1 of each Dosing Period
- A positive test for Human Immunodeficiency Virus (HIV) antibody
- Pregnant females as determined by positive serum hCG test at Screening or prior to dosing.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
- Lactating females
- 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: 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 first dosing day
Key Trial Info
Start Date :
April 24 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01827644
Start Date
April 24 2013
End Date
July 12 2013
Last Update
November 13 2017
Active Locations (1)
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1
GSK Investigational Site
Melbourne, Victoria, Australia, 3004