GSK961081 Alone and With Fluticasone Furoate (FF), Phase 1 (Ph1), Single Dose Regimen (SD), Repeat Dose Regimen (RD), Pharmacokinetic (PK) Study in Healthy Volunteer (HV)
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Keep this study
Lead
GlaxoSmithKline
With
Hammersmith Medicines Research
Age
18–64
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Between 18 and 64 years of age inclusive, at the time of signing the informed consent.
You may not be if
Body mass index (BMI) within the range 18.5-30.0 kilogram per meter square (kg/m\^2) inclusive.
Male or female:
Males: Male subjects with female partners of child bearing potential must use a condom from the time of first dose of study medication until follow-up, or have had a vasectomy with documentation of azoospermia.
Females: A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin \[hCG\] test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: Pre-menopausal females with one of the following: documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, hysterectomy, documented bilateral oophorectomy.
Post-menopausal defined as 12 months of spontaneous amenorrhea, with simultaneous follicle stimulating hormone (FSH) and oestradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods 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 enrolment.
Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) during the trial, and until follow-up. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form as described in this protocol.
Alanine aminotransferase (ALT) and bilirubin \>1.5x upper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Mean QTC \> 450 millisecond (msec). NOTES: The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine read or manually over-read.
The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial.
For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used as specified in the reporting and analysis plan (RAP).
Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or 12-lead ECG.
Pre-existing condition(s) interfering with normal gastrointestinal (GI) anatomy or motility, including constipation, malabsorption or other GI dysfunction which may interfere with the absorption, distribution, metabolism or elimination of the study drug. Subjects with a history of cholecystectomy must be excluded.
At screening, a supine blood pressure (BP) that is persistently higher (the mean of triplicate measurements taken at least 2 min apart) than 140/90 millimetres of mercury (mmHg).
At screening, a supine mean (triplicate measurements) heart rate (HR) outside the range 40-90 beats per minute (bpm).
Subject is mentally or legally incapacitated.
A history of respiratory disease in the last 10 years.
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before 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.
History of regular alcohol consumption within 6 months of the study, defined as an average weekly intake of \>21 units for males and \>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 milliliter \[mL\]) of wine or 1 (25 mL) measure of spirits.
Urinary cotinine levels indicative of smoking; current smoker; or ex-smokers who (1) gave up less than 6 months ago or (2) who have a history of more than 10 pack-years. Pack-years is equal to cigarettes per day multiplied to number of years smoked divided by 20.
History of sensitivity to any of the study medications or their components (beta agonist, anti-muscarinic, corticosteroid medication, magnesium stearate, or lactose), or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicated the subject's participation.
Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months before the first dose of study treatment.
A positive test for human immunodeficiency virus (HIV).
A positive pre-study drug/alcohol screen.
The subject has participated in a clinical trial and has received an investigational product (IP) within 3 months before their first dose in the current study.
Exposure to more than four new chemical entities within 12 months before the subject's first dose.
Unable to refrain from consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days before the first dose of study medication until the follow-up visit.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 90 day period.
Unwillingness or inability to follow the procedures outlined in the protocol.
Clareo Health | GSK961081 Alone and With Fluticasone Furoate (FF), Phase 1 (Ph1), Single Dose Regimen (SD), Repeat Dose Regimen (RD), Pharmacokinetic (PK) Study in Healthy Volunteer (HV)
