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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02348372




Registration number
NCT02348372
Ethics application status
Date submitted
5/04/2012
Date registered
28/01/2015

Titles & IDs
Public title
Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of GSK1278863A in Healthy Subjects
Scientific title
A Phase I, Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation (Part 1), Fixed Sequence and Open-Label (Part 2), Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of GSK1278863A in Healthy Subjects
Secondary ID [1] 0 0
115385
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK1278863A Placebo
Treatment: Drugs - GSK1278863A

Placebo comparator: GSK1278863A Placebo - 5, 25 and 100 mg matched

Experimental: GSK1278863A 10mg - A round, biconvex, white film coated tablet

Experimental: GSK1278863A 25mg - A round, biconvex, white film coated tablet

Experimental: GSK1278863A 50mg - A round, biconvex, white film coated tablet

Experimental: GSK1278863A 100mg - A round, biconvex, white film coated tablet


Treatment: Drugs: GSK1278863A Placebo
Matching size, shape and color

Treatment: Drugs: GSK1278863A
A round, biconvex, white film coated tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timepoint [1] 0 0
up to 96 hr
Primary outcome [2] 0 0
AUC(0-t), AUC(0-8), Cmax, tmax and t½ of GSK1278863A
Timepoint [2] 0 0
up to 96 hr
Primary outcome [3] 0 0
Changes from Baseline of Clinical laboratory tests
Timepoint [3] 0 0
0,2448 and 96 hr
Primary outcome [4] 0 0
Changes from Baseline of Vital signs
Timepoint [4] 0 0
0, 1,2,3,4,8 and 24hr
Primary outcome [5] 0 0
Change from Baseline of 12-lead ECG
Timepoint [5] 0 0
0,4 and 8 hr
Secondary outcome [1] 0 0
Hemoglobin endpoints: Hemoglobin actual values, change from baseline, rate of rise/decline, maximum change from baseline, and maximum % change from baseline
Timepoint [1] 0 0
up to 96 hr

Eligibility
Key inclusion criteria
* AST, ALT, alkaline phosphatase and bilirubin >1.5xULN.
* Healthy Male or female between 20 and 65 years of age inclusive, at the time of signing the informed consent.
* Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods.
* Body weight > 50 kg and BMI within the range 18.5 - 29.0 kg/m2 (inclusive).
* Capable of giving written informed consent.
* QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
* Japanese defined being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity papers and being able to speak Japanese. Japanese subjects should be also have lived outside Japan for less than 10 years.
* Caucasian, defined as an individual having four grandparents who are all descendents of the original peoples of Europe.
Minimum age
20 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
* A positive pre-study drug screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines
* A hemoglobin value at Screening is of: Healthy male subjects or post-menopausal females: > 16.5 g/dL, Healthy female (non-childbearing potential) subjects: > 15.5 g/dL
* The values of hematological parameters at screening are: MCV: outside the reference range and deemed clinically significant by the investigator and GSK Medical Monitor.
* The values of the following tests at Screening, for healthy subjects are: TIBC: outside the reference range of the population being studied, Serum iron: outside the reference range of the population being studied, Serum ferritin: outside the reference range of the population being studied
* A value at screening is greater than the upper limit of reference range for the following clinical laboratory parameters: AST, ALT, direct bilirubin.
* Clinically significant abnormal CPK determined by the Investigator and GSK Medical Monitor.
* Calculated creatinine clearance: < 80 mL/min
* A positive test for HIV antibody
* History of drug abuse or dependence within 6 months of the study.
* History of regular alcohol consumption within 6 months of the study
* History or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
* 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) prior to 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. By exception, subject may take acetaminophen (<2 grams/day) up to 48 hours prior to the first dose of study drug.
* 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.
* History of sensitivity to heparin or heparin-induced thrombocytopenia (if the clinical research unit uses heparin to maintain intravenous cannula).
* Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, and/or hepatic function that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Examples of conditions that could interfere with normal gastrointestinal anatomy or motility include cholecystectomy, gastrointestinal bypass surgery, partial or total gastrectomy, small bowel resection, vagotomy, malabsorption, Crohn's disease, ulcerative colitis, or celiac sprue. Examples of conditions that could interfere with hepatic function include Gilberts syndrome.
* History of peptic ulcer disease or chronic rectal bleeding.
* History of malignancy. Non-melanoma skin cancer that has been definitely removed is allowed.
* Subjects with a baseline medical history of proliferative diabetic retinopathy, preproliferative diabetic retinopathy, or wet age-related macular degeneration (AMD).
* Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
* Lactating females.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Unwillingness or inability to follow the procedures, or lifestyle and/or dietary restrictions outlined in the protocol.
* Consumption of >3 servings per day of red wine, grapefruit (juice), blood orange (juice), star fruit, onions, kale, broccoli, green beans, or apples from 7 days prior to the first dose of investigational product, unless in the opinion of the Investigator and GSK Medical Monitor this will not interfere with the study procedures and compromise subject safety.
* 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.
* 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
Crossover
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
31/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/06/2011
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick, Sydney
Recruitment postcode(s) [1] 0 0
2031 - Randwick, Sydney

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02348372