Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT02706535
Eligibility Criteria:
Inclusion Criteria:
* Between 18 and 70 years of age inclusive, at the time of signing the informed consent.
* Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, and laboratory tests.
* A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Body Weight \>=45 Kilograms (Kg) and body mass index within the range 18.0 - 29.9 Kilograms/squared meter (kg/m\^2) (inclusive) at time of screening.
* Only female subjects of non child bearing potential are eligible for screening; men are not eligible for this study. Female subjects: are eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screening and serum or urine hCG prior to dosing), is not lactating, and lacks reproductive potential, defined as:
* Pre-menopausal females with one of the following:
1. Documented tubal ligation
2. Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
3. Hysterectomy
4. Documented Bilateral Oophorectomy
* Postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)\].
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Exclusion Criteria:
* ALT and bilirubin \>1.5xupper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent).
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* Cardiac abnormalities as evidenced by any of the following:
* History or current untreated clinically significant uncontrolled arrhythmias.
* Clinically significant conduction abnormalities or arrhythmias, subjects with Bundle Branch Block
* Presence of cardiac pacemaker
* History or evidence of current \>=Class II congestive heart failure as defined by New York Heart Association (NYHA).
* History of acute coronary syndromes (including unstable angina and myocardial infarction), coronary angioplasty, or stenting.
* Any of the following ECG findings:
Baseline QT duration corrected for heart rate by Fridericia's formula (QTcF) interval \>450 miliseconds.
* History of major gastrointestinal bleeding within the last 6 months. Any evidence of active gastrointestinal bleeding excludes the subject.
* An unwillingness to abstain from all concomitant medications (excluding acetaminophen).
* History of regular alcohol consumption within 3 months of the study defined as:
•An average weekly intake of \>7 drinks for females. One drink is equivalent to 12 grams of alcohol: 12 ounces (360 millilitre \[ml\]) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
* A positive test for alcohol at screening or on admission to the clinical unit.
* A positive urine drug test at screening or on admission to the clinical unit.
* Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
* An unwillingness to abstain from caffeine- and xantheine- containing products for 24 hours prior to GSK525762 dosing until collection of the final PK sample during each PK session.
* An unwillingness to abstain from ingestion of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos within 7 days prior to the first dose of study treatment(s) or until the end of the study.
* 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 Medical Monitor, contraindicates their participation.
* Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. A positive pre-study drug/alcohol screen.
* A positive test for Human Immunodeficiency Virus antibody.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days.
* 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 longest).
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02706535
Study Brief:
Protocol Section:
NCT02706535