Asthma
Conditions
Keywords
healthy volunteer, Asthma, inhaled corticosteroid, UD-DPI, ELLIPTA DPI, Fluticasone furoate
Brief summary
This is an open-label, five- period, cross-over, randomized, single dose, single centre study in healthy subjects. This is the second clinical study for the UD-DPI. This study will ascertain whether the Pharmacokinetics (PK) systemic exposure \[in terms of area under the plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax)\] of FF delivered via the UD-DPI is comparable to the systemic exposure of FF delivered via the ELLIPTA Dry Powder Inhaler (DPI). For this reason four treatment doses consisting of three dose strengths and 2 percentage blends will be assessed when delivered via the UD-DPI. This study is designed to compare the pharmacokinetic profile of various doses and blends of FF administered via UD-DPI and relative to FF administered via ELLIPTA DPI. Subjects will be screened 28 days prior to study initiation. During each treatment period, subjects will be at study site from evening prior to dosing until completion of the 48 hour post-dose PK sample collection on Day 3. Minimum 7 days washout will be between treatments after completion of all five treatments and the follow-up visit will be conducted 7-14 days post last dose. Duration of study is 13 weeks. ELLIPTA is a registered trademark of the GSK group of companies.
Interventions
DRUGFF UD-DPI
A blister containing a small quantity of powder comprising of a blend of FF (micronised) and excipient(s) will be administered using UD-DPI. It is available in following dosages: 80mcg/Blister (0.8% Blend); 100mcg/Blister (0.8% Blend); 140mcg/Blister (0.8% Blend); 100mcg/Blister (0.6% Blend)
DRUGFF ELLIPTA DPI
A blister strip contained within the ELLIPTA device. Each blister contains a small quantity of powder comprising of a blend of FF and excipient(s) in dose 100mcg/Blister (0.8% Blend)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* AGE- Between 18 and 65 years of age inclusive, at the time of signing the informed consent * TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY * 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 if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * WEIGHT-Body Weight \>= 50 kilogram and BMI within the range 19.0 - 34.0 kilogram per square metre (inclusive) * SEX * Male, * Female subject : is eligible to participate if she is not pregnant \[as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screening or urine hCG prior to dosing\], 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 * Postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)\]. 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 below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until completion of the follow-up visit. * GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) * This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis. * Contraceptive subdermal implant that meets the SOP effectiveness criteria including a \<1% rate of failure per year, as stated in the product label * Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a \<1% rate of failure per year, as stated in the product label * Oral Contraceptive, either combined or progestogen alone * Injectable progestogen * Contraceptive vaginal ring * Percutaneous contraceptive patches * Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject * These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. * INFORMED CONSENT Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in protocol. * OTHER * Capable of using the UD-DPI and the ELLIPTA DPI adequately after training * Subjects who are current non-smokers, who have not used any tobacco products in the 6 month period preceding the screening visit, and have a pack history of \<= 5 pack years. * Number of pack years = (number of cigarettes per day/20) x number of years smoked
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC from time zero (pre-dose) to 24 hours (hr) (AUC [0-24hr]) and/ or AUC from time zero extrapolated to infinite time (AUC [0-infinity]) and/ or AUC from time zero to last time of quantifiable concentration (AUC [0-t]) | Day 1, Day 2 and Day3 of each period | AUC (0-24h) and/or AUC(0-t) and/or AUC(0- infinity) will be measured at predose, 5 minutes (min), 10 min, 20 min, 30 min and 45 min, 1 hr, 1.5 hr, 2 hr, 3 hr,4 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr and 48 hr |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Day 1, Day 2 and Day3 of each period | Cmax will be measured at predose, 5 min, 10 min, 20 min, 30 min and 45 min, 1 hr, 1.5 hr, 2 hr, 3 hr,4 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr and 48 hr |
| Time to Cmax (tmax) | Day 1, Day 2 and Day3 of each period | Tmax will be measured at predose, 5 min, 10 min, 20 min, 30 min and 45 min, 1 hr, 1.5 hr, 2 hr, 3 hr,4 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr and 48 hr |
| Safety as assessed by adverse events (AE) | Up to Week 13 | An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product |
| Safety as assessed by 12 Lead Electrocardiogram (ECG) Parameters | Day 1 in each period | Single 12-lead ECGs will be measured in a semi-supine position at each timepoint during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT duration corrected |
| Safety as assessed by Vital signs | Day 1, Day 3 in each period | Vital signs include temperature, systolic and diastolic blood pressure, heart rate |
Countries
Australia
Outcome results
None listed