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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01202214




Registration number
NCT01202214
Ethics application status
Date submitted
13/09/2010
Date registered
15/09/2010
Date last updated
31/01/2011

Titles & IDs
Public title
Repeat Dose Safety Study for Compound to Treat Asthma
Scientific title
A Randomized, Single-Blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GSK1440115 After a Single Dose and 7 Days of Repeat Dosing in Healthy Volunteers
Secondary ID [1] 0 0
UR2114661
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo

Experimental: Active drug -

Placebo comparator: Placebo -


Treatment: Drugs: Placebo
matching placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability assessments consisting of Adverse Events, ECGs, vital signs, clinical observations, and clinical laboratory tests
Timepoint [1] 0 0
Throughout study
Primary outcome [2] 0 0
Plasma drug concentration versus time curve [AUC (0-t), AUC [0-8], AUC(0-t)], maximum Cmax, tmax, and t1/2 of GSK1140115 as data permit
Timepoint [2] 0 0
Duration of dosing
Secondary outcome [1] 0 0
Blood pressure (BP) and heart rate (HR)
Timepoint [1] 0 0
Duration of dosing
Secondary outcome [2] 0 0
Peak expiratory flow rate (PEFR)
Timepoint [2] 0 0
Duration of Dosing

Eligibility
Key inclusion criteria
1. 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.
2. Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
3. 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 (<147 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 will 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.]
4. Male subjects with female partners of child-bearing potential 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 drug until completion of the Follow-up Period.
5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
6. AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
7. QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Screening
2. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
3. A positive pre-study drug/alcohol screen.
4. A positive test for HIV antibody.
5. Average systolic blood pressure of < 100 mmHg at Screening.
6. 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.
7. 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).
8. 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 medication is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study drug, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
9. 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.
10. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
11. Pregnant females as determined by positive serum or urine hCG test at Screening or prior to dosing.
12. Lactating females.
13. Unwillingness or inability to follow the procedures outlined in the protocol.
14. Subject is mentally or legally incapacitated.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Accenture
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to describe the safety and tolerability of single and repeat oral doses of GSK1440115 in healthy volunteers.
Trial website
https://clinicaltrials.gov/study/NCT01202214
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01202214