Wound HealingPhase 1NCT01831804

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863

A Phase 1 study testing GSK1278863 in people with Wound Healing, run by GlaxoSmithKline at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Wound Healing
What is being tested?: GSK1278863
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: 7 sitesUnited States
Study dates: 17 Jun 2013to 10 Feb 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5xupper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
[Single] corrected QT interval (QTc) < 450 millisecond (msec).
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram (ECGs). 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 GlaxoSmithKline (GSK) Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with hemoglobin (Hb) values higher than ULN the normal range should always be excluded from enrollment.
Male or female between 18 and 90 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of non-childbearing potential (postmenopausal or pre-menopausal females with a documented tubal ligation or hysterectomy). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in the protocol.
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in the protocol.

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Inclusion Criteria - DFU Subjects must meet healthy volunteer inclusion criteria and the following
Diagnosed with Type I or Type II diabetes mellitus.
Glycosylated haemoglobin (HbA1c) <=12%.
QTc < 480 msec in subjects with bundle branch block.
Lower extremity diabetic foot ulcer of 30 to 364 days' duration.
DFU between 1 centimeter squared (cm ^2) and 20 cm^2 at screening.
Presence of at least one DFU that meets all of the following criteria: (a). Ulcer has been diagnosed as a full-thickness, neuropathic DFU and is located at or distal to the malleolus (excluding ulcers between the toes but including those of the heel). (b). There is a minimum 2 cm margin between the qualifying study ulcer and any other ulcers on the specified foot. (c). Ulcer size (area) >=1 cm^2 and <=12 cm^2 (post-debridement at time of randomization). (d). Wagner Grade 1. (e). Depth <=5 millimeter (mm) with no capsule, tendon or bone exposed and no tunneling, undermining, or sinus tracts. Note: If the subject has more than one qualifying DFU, the ulcer designated as the study ulcer will be at the discretion of the Investigator. Non-study ulcers being treated during the course of the study will be treated with moist wound therapy Standard of Care (SOC) identified under this study.
Adequate vascular perfusion of the affected limb within 30 days of screening, as defined by at least one of the following: (a) Transcutaneous oxygen partial pressure (TcPO2) >35 millimeter of mercury (mmHg). (b) Ankle-Brachial Index (ABI) >=0.6 and <=1.2, confirmed by TcPO2 >35 mmHg. (c) Toe pressure (plethysmography) >50 mmHg. (d) Doppler ultrasound (biphasic or triphasic waveforms) consistent with adequate blood flow to the affected extremity, as determined by SOC.

Who cannot join

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of malignancy within 5 years of Screening or those with a strong family history of cancer (e.g., familial cancer disorders), with the exception of squamous cell or basal cell carcinoma of the skin that has been definitively treated.
A history of drug or alcohol abuse, or a history of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram of alcohol: 12 ounces (360 mililiter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
A positive test for human immunodeficiency virus (HIV) antibody.
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 (whichever is longer).

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Unable to refrain from the 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 GlaxoSmithKline (GSK) Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
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.
Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period.
Pregnant females as determined by positive urine human chorionic gonadotropin test at screening or prior to dosing.
Unwillingness or inability to follow the procedures outlined in the protocol.
Subject is mentally or legally incapacitated. Exclusion Criteria - DFU Subjects
Healthy volunteer exclusions apply to DFU subjects in addition to the following:
Subjects with ulcers accompanied by infected cellulitis, osteomyelitis, or clinical signs or symptoms of infection, Gangrene on any part of affected limb, Active Charcot's foot on the study limb, Planned vascular surgery, angioplasty or thrombolysis, Ulcers involving exposure of tendon, bone, or joint capsule (It is acceptable to have ulcers extending through the dermis and into subcutaneous tissue with presence of granulation tissue), Ulcers due to non-diabetic etiology.
Any unstable vascular syndromes (such as transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, acute myocardial infarction (MI) or acute coronary syndrome event (ACS) and/or any major changes (per investigator's judgment) to related medications within 6 months prior to randomization.
History or malignancy within 5 years of screening or those with a strong family history of cancer (e.g. familial cancer disorders), with the exception of squamous cell or basal cell carcinoma of the skin that has been definitively treated.
Other clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the Investigator or the GSK Medical Monitor, not stabilized or may otherwise impact the results of the study.
Patients with active treatment for retinal neovascularization (e.g., diabetic proliferative retinopathy or age related macular degeneration) within 6 months of randomization.
Patients undergoing hemodialysis.
History of venous thrombosis defined as deep vein thrombosis, pulmonary embolism or other venous thrombotic condition within 1 year prior to screening.
Active peptic, duodenal, or esophageal ulcer disease or any gastrointestinal bleeding, within 1 year prior to screening.
Subjects with a platelet count <100,000/mm^3 at screening.
Subjects with an International Normalized Ratio (INR) >1.5 at screening.
Subjects with a hemoglobin level above the gender-specific upper limit of normal at screening.
Subjects with a history of non-traumatic joint inflammation (with the exception of inflammation due to osteoarthritis).
Patients with known pulmonary hypertension.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

GSK Investigational Site
Castro Valley, California, 94546
GSK Investigational Site
Dallas, Texas, 75390
GSK Investigational Site
Las Vegas, Nevada, 89106
GSK Investigational Site
Miami, Florida, 33176
GSK Investigational Site
Pinellas Park, Florida, 33782
GSK Investigational Site
Providence, Rhode Island, 02903
GSK Investigational Site
Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Topical GSK1278863 in Healthy Volunteers and Diabetic Patients, and Repeat Doses of GSK1278863 in Diabetic Patients for the Treatment of Diabetic Foot Ulcer

This is a randomized, placebo-controlled, single-blind (subjects and investigators will be blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part B) trial in healthy volunteers and subjects with diabetic foot ulcers. Part A is designed to evaluate single applications of GSK1278863 in one cohort of healthy volunteers (intact skin) and approximately 3 cohorts of diabetic subjects. Part B is designed to evaluate first single, and then repeat applications of GSK1278863 in diabetics, both in the clinic and by subjects at home. Part B will include approximately 3 cohorts in which the concentration of drug applied will be determined by pharmacokinetic data from Part A and earlier cohorts in Part B.

Conditions: Wound Healing
Being tested: GSK1278863, Placebo
Keywords: diabetic foot ulcer, pharmacodynamics, pharmacokinetics, ischemic
Medical subject headings: Diabetic Foot, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK1278863Drug
White to off-white smooth ointment with unit dose strength of 0.05%w/w, 0.1%w/w, 0.5%w/w, 1.0%w/w for topical application as single or repeat doses.
PlaceboDrug
White to off-white smooth ointment for topical application as single or repeat doses.

Study groups in NCT01831804
Study group	Role	What they receive
Cohort 1 Part A	Experimental	Healthy subjects in this arm will receive single applications of GSK1278863 or placebo (with 6:2 ratio) on intact skin in two escalating dosing periods each separated by 10 days. The first application will be with a single dose of 0.3 mg and second application will be single dose of 3 mg. Receives: Drug: GSK1278863; Drug: Placebo
Cohort 2 Part A	Experimental	Subjects with diabetic foot ulcer (DFU) will receive a single application of GSK1278863 or placebo (with 6:2 ratio) in two dosing periods separated by 10 days. The first application will be made on intact skin and second application directly on DFU. Dose will be based on wound area and review from previous cohort data. Receives: Drug: GSK1278863; Drug: Placebo
Cohort 3 Part A	Experimental	Subjects with DFU will receive single application of GSK1278863 or placebo directly on DFU. Dose will be based on wound area and review from previous cohort data. Receives: Drug: GSK1278863; Drug: Placebo
Cohort 4 Part A	Experimental	Subjects with DFU will receive a single application of GSK1278863 or placebo (with 6:2 ratio) in two dosing periods separated by 10 days. The first application will be made on DFU and second application on intact skin. Dose will be based on wound area and review from previous cohort data. Receives: Drug: GSK1278863; Drug: Placebo
Cohort 5 Part B	Experimental	Subjects with DFU will receive Standard of care (SOC) up to 15 days and then will be randomized to one of the three arms: GSK1278863 + SOC, or SOC only, or placebo + SOC with ratio of 12:2:2. Doses for the cohorts in Part B will be determined from safety, tolerability and PK data from Part A. subjects will first be given a single application of GSK1278863 or placebo at the dose chosen for that cohort, followed by a 7-day washout period, and then repeat applications for 14 days, starting on Day 8. Receives: Drug: GSK1278863; Drug: Placebo
Cohort 6 Part B	Experimental	Subjects with DFU will receive Standard of care (SOC) up to 15 days and then will be randomized to one of the three arms: GSK1278863 + SOC, or SOC only, or placebo + SOC with ratio of 12:2:2. Doses for the cohorts in Part B will be determined from safety, tolerability and PK data from Part A. subjects will first be given a single application of GSK1278863 or placebo at the dose chosen for that cohort, followed by a 7-day washout period, and then repeat applications for 14 days, starting on Day 8. Receives: Drug: GSK1278863; Drug: Placebo
Cohort 7 Part B	Experimental	Subjects with DFU will receive Standard of care (SOC) up to 15 days and then will be randomized to one of the three arms: GSK1278863 + SOC, or SOC only, or placebo + SOC with ratio of 12:2:2. Doses for the cohorts in Part B will be determined from safety, tolerability and PK data from Part A. subjects will first be given a single application of GSK1278863 or placebo at the dose chosen for that cohort, followed by a 7-day washout period, and then repeat applications for 14 days, starting on Day 8. Receives: Drug: GSK1278863; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events; or is associated with liver injury and impaired liver function.
Measured: Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose])
Number of Participants With AEs and SAEs Following Repeat Dose Administration (Part B)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events; or is associated with liver injury and impaired liver function.
Measured: Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose])
Number of Participants With Clinically Significant 12-lead Electrocardiograms (ECGs) Measurement Following Single Dose Administrations (Part A)
ECG measurements were taken with the participants in supine position for at least 5 minutes. The number of participants with clinically significant abnormal ECG measurement following single dose administration for worst case post-Baseline visit has been presented.
Measured: Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose])
Number of Participants With Clinically Significant 12-lead ECG Measurement Following Repeat Dose Administrations (Part B)
ECG measurements were taken with the participants in supine position for at least 5 minutes. The number of participants with clinically significant abnormal ECG measurement following single dose administration for worst case post-Baseline visit has been presented.
Measured: Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose])
Number of Participants With Vital Sign Data Outside Clinical Concern Range Following Single Dose Administration (Part A)
Vital sign measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Vital signs were measured after the participants rested in a supine or semi-supine position for 5 minutes prior to the procedure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter.
Measured: Day 1 (pre-dose and 48 hours) of Periods 1 and 2
Number of Participants With Vital Sign Data Outside Clinical Concern Range Following Repeat Dose Administration (Part B)
Vital sign measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Vital signs were measured after the participants rested in a supine or semi-supine position for 5 minutes prior to the procedure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter.
Measured: Days 1 and 7 (pre-dose), Day 14 (24 hours)
Number of Participants With Abnormal Nurse/Physician Observation (Part A)
A brief physical assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen) were planned to be performed by qualified licensed, medical professional (i.e., physician, physician assistant, or nurse practitioner) but was not performed.Since data was not collected, no analysis was performed.
Measured: Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose])
Number of Participants With Abnormal Nurse/Physician Observation (Part B)
A brief physical assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen) were planned to be performed by qualified licensed, medical professional (i.e., physician, physician assistant, or nurse practitioner) but was not performed. Since data was not collected, no analysis was performed.
Measured: Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose])
Number of Participants With Hematology Values Outside the Clinical Concern Range (Part A)
Hematology parameters assessed were: platelet count, red blood cell count, white blood cell count, hemoglobin, reticulocyte count, hematocrit, absolute neutrophil count (ANC), monocytes, lymphocytes, eosinophils, basophils, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration. When a high or low value was reported, all values are presented for that time point and parameter.
Measured: Day 1 (pre-dose)
Number of Participants With Hematology Data Outside the Clinical Concern Range (Part B)
Hematology parameters assessed were: platelet count, red blood cell count, white blood cell count, hemoglobin, reticulocyte count, hematocrit, neutrophils, monocytes, lymphocytes, eosinophils, basophils, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration. When a high or low value was reported, all values are presented for that time point and parameter.
Measured: Day 1 (pre-dose)
Number of Participants With Clinical Chemistry Values Outside the Clinical Concern Range (Part A)
Chemistry parameters assessed were: Blood urea nitrogen (BUN), creatinine, fasting glucose, sodium, creatine phosphokinase (CPK), potassium, chloride, total carbon dioxide (CO2), calcium, glycosylated hemoglobin (HbA1C), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Gamma glutamyltransferase (GGT), Alkaline phosphatase (ALP), High sensitivity C-reactive protein (hsCRP), total and direct bilirubin, uric acid, albumin and total protein. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter.
Measured: Day 1 (pre-dose and 48 hours) in period 1; Day 1 (48 hours) in period 2
Number of Participants With Clinical Chemistry Values Outside the Clinical Concern Range (Part B)
Chemistry parameters assessed were: Blood urea nitrogen (BUN), creatinine, fasting glucose, sodium, creatine phosphokinase (CPK), potassium, chloride, total carbon dioxide (CO2), calcium, glycosylated hemoglobin (HbA1C), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Gamma glutamyltransferase (GGT), Alkaline phosphatase (ALP), High sensitivity C-reactive protein (hsCRP), total and direct bilirubin, uric acid, albumin and total protein. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter.
Measured: Days 1 and 7 (pre-dose) and Day 14 (24 hours)
Maximum Observed Concentration (Cmax) of GSK1278863 (Part A)
The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Cmax could not be determined as data was below the limit of quantification.
Measured: Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hrs post-dose
Cmax of GSK1278863 (Part B)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Cmax could not be determined as data was below the limit of quantification.
Measured: Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14
Time of Occurrence of Cmax (Tmax) of GSK1278863 (Part A)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tmax could not be determined as data was below the limit of quantification.
Measured: Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose
Tmax of GSK1278863 (Part B)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tmax could not be determined as data was below the limit of quantification.
Measured: Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14
Apparent Terminal Elimination Half-life (t1/2) of GSK1278863 (Part A)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. t1/2 could not be determined as data was below the limit of quantification.
Measured: Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose
t1/2 of GSK1278863 (Part B)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. t1/2 could not be determined as data was below the limit of quantification.
Measured: Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14
Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) (Part A)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tlag could not be determined as data was below the limit of quantification.
Measured: Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose
Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) (Part B)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tlag could not be determined as data was below the limit of quantification.
Measured: Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] of GSK1278863 (Part A)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-inf) could not be determined as data was below the limit of quantification.
Measured: Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose
AUC(0-inf) of GSK1278863 (Part B)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-inf) could not be determined as data was below the limit of quantification.
Measured: Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments [AUC(0-t)] of GSK1278863 (Part A)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-t) could not be determined as data was below the limit of quantification.
Measured: Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hrs post-dose
AUC(0-t) of GSK1278863 (Part B)
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-t) could not be determined as data was below the limit of quantification.
Measured: Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jun 201310 Feb 2017

First posted15 Apr 2013 (estimated)
Study start17 Jun 2013
Primary completion10 Feb 2017
Study completion10 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Wound HealingStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01831804
Sponsor's protocol ID: 115760
Status last verified: Jun 2019
First submitted: 11 Apr 2013
Last updated: 19 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Olson E, Mahar KM, Morgan L, Fillmore C, Holland C, Lavery L. Randomized Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Topical Daprodustat in Healthy Volunteers and in Patients With Diabetic Foot Ulcers. Clin Pharmacol Drug Dev. 2019 Aug;8(6):765-778. doi: 10.1002/cpdd.654. Epub 2019 Feb 5.
PubMed 30720931

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Topical GSK1278863 in Healthy Volunteers and Diabetic Patients, and Repeat Doses of GSK1278863 in Diabetic Patients for the Treatment of Diabetic Foot Ulcer
ClinicalTrials.gov ID: NCT01831804
Acronym / sponsor ID: 115760
Conditions: Wound Healing
Keywords: diabetic foot ulcer, pharmacodynamics, pharmacokinetics, ischemic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 17 Jun 2013 (actual)
Primary completion: 10 Feb 2017 (actual)
Study completion: 10 Feb 2017 (actual)
First posted: 15 Apr 2013 (estimated)
Results: Posted 19 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 7

Arm	Type	Receives
Cohort 1 Part A	Experimental	Drug: GSK1278863, Drug: PlaceboHealthy subjects in this arm will receive single applications of GSK1278863 or placebo (with 6:2 ratio) on intact skin in two escalating dosing periods each separated by 10 days. The first application will be with a single dose of 0.3 mg and second application will be single dose of 3 mg.
Cohort 2 Part A	Experimental	Drug: GSK1278863, Drug: PlaceboSubjects with diabetic foot ulcer (DFU) will receive a single application of GSK1278863 or placebo (with 6:2 ratio) in two dosing periods separated by 10 days. The first application will be made on intact skin and second application directly on DFU. Dose will be based on wound area and review from previous cohort data.
Cohort 3 Part A	Experimental	Drug: GSK1278863, Drug: PlaceboSubjects with DFU will receive single application of GSK1278863 or placebo directly on DFU. Dose will be based on wound area and review from previous cohort data.
Cohort 4 Part A	Experimental	Drug: GSK1278863, Drug: PlaceboSubjects with DFU will receive a single application of GSK1278863 or placebo (with 6:2 ratio) in two dosing periods separated by 10 days. The first application will be made on DFU and second application on intact skin. Dose will be based on wound area and review from previous cohort data.
Cohort 5 Part B	Experimental	Drug: GSK1278863, Drug: PlaceboSubjects with DFU will receive Standard of care (SOC) up to 15 days and then will be randomized to one of the three arms: GSK1278863 + SOC, or SOC only, or placebo + SOC with ratio of 12:2:2. Doses for the cohorts in Part B will be determined from safety, tolerability and PK data from Part A. subjects will first be given a single application of GSK1278863 or placebo at the dose chosen for that cohort, followed by a 7-day washout period, and then repeat applications for 14 days, starting on Day 8.
Cohort 6 Part B	Experimental	Drug: GSK1278863, Drug: PlaceboSubjects with DFU will receive Standard of care (SOC) up to 15 days and then will be randomized to one of the three arms: GSK1278863 + SOC, or SOC only, or placebo + SOC with ratio of 12:2:2. Doses for the cohorts in Part B will be determined from safety, tolerability and PK data from Part A. subjects will first be given a single application of GSK1278863 or placebo at the dose chosen for that cohort, followed by a 7-day washout period, and then repeat applications for 14 days, starting on Day 8.
Cohort 7 Part B	Experimental	Drug: GSK1278863, Drug: PlaceboSubjects with DFU will receive Standard of care (SOC) up to 15 days and then will be randomized to one of the three arms: GSK1278863 + SOC, or SOC only, or placebo + SOC with ratio of 12:2:2. Doses for the cohorts in Part B will be determined from safety, tolerability and PK data from Part A. subjects will first be given a single application of GSK1278863 or placebo at the dose chosen for that cohort, followed by a 7-day washout period, and then repeat applications for 14 days, starting on Day 8.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5xupper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
[Single] corrected QT interval (QTc) < 450 millisecond (msec).
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram (ECGs). 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 GlaxoSmithKline (GSK) Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with hemoglobin (Hb) values higher than ULN the normal range should always be excluded from enrollment.
Male or female between 18 and 90 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of non-childbearing potential (postmenopausal or pre-menopausal females with a documented tubal ligation or hysterectomy). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in the protocol.

Key exclusion criteria (26 listed)

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of malignancy within 5 years of Screening or those with a strong family history of cancer (e.g., familial cancer disorders), with the exception of squamous cell or basal cell carcinoma of the skin that has been definitively treated.
A history of drug or alcohol abuse, or a history of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram of alcohol: 12 ounces (360 mililiter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
A positive test for human immunodeficiency virus (HIV) antibody.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK1278863White to off-white smooth ointment with unit dose strength of 0.05%w/w, 0.1%w/w, 0.5%w/w, 1.0%w/w for topical application as single or repeat doses.	Drug	Cohort 1 Part A, Cohort 2 Part A, Cohort 3 Part A, Cohort 4 Part A, Cohort 5 Part B, Cohort 6 Part B, Cohort 7 Part B
PlaceboWhite to off-white smooth ointment for topical application as single or repeat doses.	Drug	Cohort 1 Part A, Cohort 2 Part A, Cohort 3 Part A, Cohort 4 Part A, Cohort 5 Part B, Cohort 6 Part B, Cohort 7 Part B

Primary outcome

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A)
Time frame: Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose])
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events; or is associated with liver injury and impaired liver function.
Number of Participants With AEs and SAEs Following Repeat Dose Administration (Part B)
Time frame: Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose])
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events; or is associated with liver injury and impaired liver function.
Number of Participants With Clinically Significant 12-lead Electrocardiograms (ECGs) Measurement Following Single Dose Administrations (Part A)
Time frame: Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose])
ECG measurements were taken with the participants in supine position for at least 5 minutes. The number of participants with clinically significant abnormal ECG measurement following single dose administration for worst case post-Baseline visit has been presented.
Number of Participants With Clinically Significant 12-lead ECG Measurement Following Repeat Dose Administrations (Part B)
Time frame: Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose])
ECG measurements were taken with the participants in supine position for at least 5 minutes. The number of participants with clinically significant abnormal ECG measurement following single dose administration for worst case post-Baseline visit has been presented.
Number of Participants With Vital Sign Data Outside Clinical Concern Range Following Single Dose Administration (Part A)
Time frame: Day 1 (pre-dose and 48 hours) of Periods 1 and 2
Vital sign measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Vital signs were measured after the participants rested in a supine or semi-supine position for 5 minutes prior to the procedure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter.
Number of Participants With Vital Sign Data Outside Clinical Concern Range Following Repeat Dose Administration (Part B)
Time frame: Days 1 and 7 (pre-dose), Day 14 (24 hours)
Vital sign measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Vital signs were measured after the participants rested in a supine or semi-supine position for 5 minutes prior to the procedure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter.
Number of Participants With Abnormal Nurse/Physician Observation (Part A)
Time frame: Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose])
A brief physical assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen) were planned to be performed by qualified licensed, medical professional (i.e., physician, physician assistant, or nurse practitioner) but was not performed.Since data was not collected, no analysis was performed.
Number of Participants With Abnormal Nurse/Physician Observation (Part B)
Time frame: Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose])
A brief physical assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen) were planned to be performed by qualified licensed, medical professional (i.e., physician, physician assistant, or nurse practitioner) but was not performed. Since data was not collected, no analysis was performed.
Number of Participants With Hematology Values Outside the Clinical Concern Range (Part A)
Time frame: Day 1 (pre-dose)
Hematology parameters assessed were: platelet count, red blood cell count, white blood cell count, hemoglobin, reticulocyte count, hematocrit, absolute neutrophil count (ANC), monocytes, lymphocytes, eosinophils, basophils, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration. When a high or low value was reported, all values are presented for that time point and parameter.
Number of Participants With Hematology Data Outside the Clinical Concern Range (Part B)
Time frame: Day 1 (pre-dose)
Hematology parameters assessed were: platelet count, red blood cell count, white blood cell count, hemoglobin, reticulocyte count, hematocrit, neutrophils, monocytes, lymphocytes, eosinophils, basophils, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration. When a high or low value was reported, all values are presented for that time point and parameter.
Number of Participants With Clinical Chemistry Values Outside the Clinical Concern Range (Part A)
Time frame: Day 1 (pre-dose and 48 hours) in period 1; Day 1 (48 hours) in period 2
Chemistry parameters assessed were: Blood urea nitrogen (BUN), creatinine, fasting glucose, sodium, creatine phosphokinase (CPK), potassium, chloride, total carbon dioxide (CO2), calcium, glycosylated hemoglobin (HbA1C), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Gamma glutamyltransferase (GGT), Alkaline phosphatase (ALP), High sensitivity C-reactive protein (hsCRP), total and direct bilirubin, uric acid, albumin and total protein. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter.
Number of Participants With Clinical Chemistry Values Outside the Clinical Concern Range (Part B)
Time frame: Days 1 and 7 (pre-dose) and Day 14 (24 hours)
Chemistry parameters assessed were: Blood urea nitrogen (BUN), creatinine, fasting glucose, sodium, creatine phosphokinase (CPK), potassium, chloride, total carbon dioxide (CO2), calcium, glycosylated hemoglobin (HbA1C), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Gamma glutamyltransferase (GGT), Alkaline phosphatase (ALP), High sensitivity C-reactive protein (hsCRP), total and direct bilirubin, uric acid, albumin and total protein. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter.
Maximum Observed Concentration (Cmax) of GSK1278863 (Part A)
Time frame: Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hrs post-dose
The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Cmax could not be determined as data was below the limit of quantification.
Cmax of GSK1278863 (Part B)
Time frame: Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Cmax could not be determined as data was below the limit of quantification.
Time of Occurrence of Cmax (Tmax) of GSK1278863 (Part A)
Time frame: Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tmax could not be determined as data was below the limit of quantification.
Tmax of GSK1278863 (Part B)
Time frame: Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tmax could not be determined as data was below the limit of quantification.
Apparent Terminal Elimination Half-life (t1/2) of GSK1278863 (Part A)
Time frame: Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. t1/2 could not be determined as data was below the limit of quantification.
t1/2 of GSK1278863 (Part B)
Time frame: Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. t1/2 could not be determined as data was below the limit of quantification.
Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) (Part A)
Time frame: Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tlag could not be determined as data was below the limit of quantification.
Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) (Part B)
Time frame: Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tlag could not be determined as data was below the limit of quantification.
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] of GSK1278863 (Part A)
Time frame: Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-inf) could not be determined as data was below the limit of quantification.
AUC(0-inf) of GSK1278863 (Part B)
Time frame: Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-inf) could not be determined as data was below the limit of quantification.
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments [AUC(0-t)] of GSK1278863 (Part A)
Time frame: Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hrs post-dose
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-t) could not be determined as data was below the limit of quantification.
AUC(0-t) of GSK1278863 (Part B)
Time frame: Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14
The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-t) could not be determined as data was below the limit of quantification.

Results and safety

Results posted to the registry on 19 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo HVT (Cohort 1)	4	3
Placebo DFU SD (Cohort 2, 3, 4)	3	1
A/B (Cohort 1)	9	3
C/C (Cohort 2)	5	5
D (Cohort 3)	5	3
E/E (Cohort 4)	3	3
Placebo DFU RD (Cohort 5)	4	3
R1r (Cohort 5)	26	23
Sr (Cohort 5)	4	2

Primary outcome: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A)

Time frame: Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose]). Number. Unit: Participants

Measure	Placebo HVT (Cohort 1) n = 4	A/B (Cohort 1) n = 9	Placebo DFU SD (Cohort 2, 3, 4) n = 3	C (Cohort 2) n = 5	D (Cohort 3) n = 5	E (Cohort 4) n = 3
AEs	2	3	1	0	2	1
SAEs	0	0	0	0	0	1

Population analysed: All Subject Population comprised of all participants who received at least one dose of study drug (including GSK1278863, placebo and standard care).

Primary outcome: Number of Participants With AEs and SAEs Following Repeat Dose Administration (Part B)

Time frame: Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose]). Number. Unit: Participants

Measure	Placebo DFU RD (Cohort 5) n = 4	R1r (Cohort 5) n = 26	Sr (Cohort 5) n = 4
AEs	2	5	2
SAEs	1	0	1

Population analysed: All Subject Population.

Primary outcome: Number of Participants With Clinically Significant 12-lead Electrocardiograms (ECGs) Measurement Following Single Dose Administrations (Part A)

Time frame: Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose]). Number. Unit: Participants

Measure	Placebo HVT (Cohort 1) n = 4	Placebo DFU SD (Cohort 2, 3, 4) n = 3	A/B (Cohort 1) n = 9	C/C (Cohort 2) n = 5	D (Cohort 3) n = 5	E/E (Cohort 4) n = 3
Value	0	0	0	0	0	0

Population analysed: All Subject Population

Primary outcome: Number of Participants With Clinically Significant 12-lead ECG Measurement Following Repeat Dose Administrations (Part B)

Time frame: Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose]). Number. Unit: Participants

Measure	Placebo DFU RD (Cohort 5) n = 4	R1r (Cohort 5) n = 26	Sr (Cohort 5) n = 4
Value	0	0	0

Population analysed: All Subject Population

Adverse events

Time frame: SAEs and non-serious AEs were collected from start of study treatment through the final follow-up visit each of Part A {up to a maximum of 75 days (start of study treatment through final follow up 2 [28-32 days post last dose])} and B {up to a maximum of 53 days (start of study treatment through final follow up 2 [28-32 days post last dose])}. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo HVT (Cohort 1)	0 of 4 (0%)	1 of 4 (25%)	0 of 4
A/B (Cohort 1)	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
Placebo DFU SD (Cohort 2, 3, 4)	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
C (Cohort 2)	0 of 5 (0%)	0 of 5 (0%)	0 of 5
D (Cohort 3)	0 of 5 (0%)	0 of 5 (0%)	0 of 5
E (Cohort 4)	1 of 3 (33.3%)	1 of 3 (33.3%)	0 of 3
Placebo DFU RD (Cohort 5)	1 of 4 (25%)	1 of 4 (25%)	0 of 4
R1r (Cohort 5)	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Sr (Cohort 5)	1 of 4 (25%)	1 of 4 (25%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30720931Olson E, Mahar KM, Morgan L, Fillmore C, Holland C, Lavery L. Randomized Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Topical Daprodustat in Healthy Volunteers and in Patients With Diabetic Foot Ulcers. Clin Pharmacol Drug Dev. 2019 Aug;8(6):765-778. doi: 10.1002/cpdd.654. Epub 2019 Feb 5.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK1278863 in people with Wound Healing, run by GlaxoSmithKline at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) (time frame: Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose])). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01831804, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.