Last updated: 07/14/2020 13:10:05
A study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1278863A in healthy subjects
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase I, Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of GSK1278863A in Healthy Subjects
Trial description: A first-time in human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1278863A in healthy subjects
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
GSK1278863A safety endpoints: adverse events reporting, clinical safety laboratory tests (hematology, chemistry, urinalysis,and fecal occult blood), vital signs, 12-lead ECG, dual-lead cardiac monitoring.
Timeframe: 1 Day
Secondary outcomes:
Blood and urine levels of GSK1278863A
Timeframe: 2 Days
Effect of GSK1278863A on hematological markers
Timeframe: 2 Days
Interventions:
Enrollment:
36
Primary completion date:
2008-12-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Anaemia
Product
daprodustat
Collaborators
Not applicable
Study date(s)
July 2008 to December 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Healthy, non-smoking (within 40 days of screening), adult males and females between 18 and 55 years of age, inclusive
- Female subjects are eligible for participation in the study if they are of:
- MCV value outside the reference range at screening
- Hemoglobin value at screening is: male subjects or post-menopausal females > 15.5 g/dL; female subjects > 14.5 g/dL
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy, non-smoking (within 40 days of screening), adult males and females between 18 and 55 years of age, inclusive
- Female subjects are eligible for participation in the study if they are of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant);
- Male subjects agree to use contraception methods
- Body weight > or = 50 kg; BMI: 19-31 kg/m2, inclusive
- Subject has a QTc <450 msec or <480 msec if associated with bundle branch block
- Subject is willing and able to provide written informed consent
Exclusion criteria:
- MCV value outside the reference range at screening
- Hemoglobin value at screening is: male subjects or post-menopausal females > 15.5 g/dL; female subjects > 14.5 g/dL
- TIBC, serum iron and serum ferritin values are outside the reference range at screening
- Calculated creatinine clearance < 60 ml/min
- Clinically significant abnormal CPK determined by the investigator and medical monitor
- AST, ALT and direct bilirubin are greater than upper limit of reference range at screening
- Subjects are unwilling or inability to follow the procedures and lifestyle and/or dietary restrictions outlined in the protocol
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor this will not interfere with the study procedures or compromise subject safety
- Subject currently exposures to more than four new chemical entities within 12 months prior to the first dosing day
- Use of other prescription or non-prescription drugs, vitamins, herbal and dietary supplements, within 7 days prior to the first dose of study medication
- Subject has a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy
- Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs.
- Subject has a history of GI ulceration or gastrointestinal bleeding
- Subject has a history of peptic ulcer disease
- Subject has a history of malignancy tumor; non-melanoma skin cancer that has been definitely removed is allowed
- Treatment with an investigational drug within 30 days preceding the first dose of study medication
- Subjects with a history of drug abuse
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening
- Positive urine drug screen (UDS) at screening
- Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result or positive HIV result within 3 months of screening
- Donation of blood in excess of 500 mL within 56 days prior to first dose of study medication
- Subject has a history of regular use of tobacco- or nicotine containing products
- History of sensitivity to heparin, heparin-induced thrombocytopenia or sensitivity to any of the study medications or components thereof
Trial location(s)
Location
GSK Investigational Site
Evansville, Indiana, United States, 47710
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2008-12-12
Actual study completion date
2008-12-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study PHX111427 can be found on the GSK Clinical Study Register.
Click hereAccess to clinical trial data by researchers
Visit website