Trial · NCT01831804
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863
NCT01831804, Phase 1, Completed, GlaxoSmithKline; results first posted 2019-08-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863. Trials, record NCT01831804. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01831804
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863
- NCT number
- NCT01831804
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 65 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Wound Healing
- Interventions
- GSK1278863, Placebo
- First posted
- 2013-04-15
- Last updated
- 2019-08-19
- Results first posted
- 2019-08-19
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) | 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. |
| Primary | Number of Participants With AEs and SAEs Following Repeat Dose Administration (Part B) | 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. |
| Primary | Number of Participants With Clinically Significant 12-lead Electrocardiograms (ECGs) Measurement Following Single Dose Administrations (Part A) | 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. |
| Primary | Number of Participants With Clinically Significant 12-lead ECG Measurement Following Repeat Dose Administrations (Part B) | 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. |
| Primary | Number of Participants With Vital Sign Data Outside Clinical Concern Range Following Single Dose Administration (Part A) | 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. |
| Primary | Number of Participants With Vital Sign Data Outside Clinical Concern Range Following Repeat Dose Administration (Part B) | 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. |
| Primary | Number of Participants With Abnormal Nurse/Physician Observation (Part A) | 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. |
| Primary | Number of Participants With Abnormal Nurse/Physician Observation (Part B) | 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. |
| Primary | Number of Participants With Hematology Values Outside the Clinical Concern Range (Part A) | 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. |
| Primary | Number of Participants With Hematology Data Outside the Clinical Concern Range (Part B) | 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. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) | Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | All Subject Population comprised of all participants who received at least one dose of study drug (including GSK1278863, placebo and standard care). | Participants | NUMBER |
| PRIMARY | Number of Participants With AEs and SAEs Following Repeat Dose Administration (Part B) | Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | All Subject Population. | Participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant 12-lead Electrocardiograms (ECGs) Measurement Following Single Dose Administrations (Part A) | Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | All Subject Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant 12-lead ECG Measurement Following Repeat Dose Administrations (Part B) | Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | All Subject Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Vital Sign Data Outside Clinical Concern Range Following Single Dose Administration (Part A) | Day 1 (pre-dose and 48 hours) of Periods 1 and 2 | All Subject Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Vital Sign Data Outside Clinical Concern Range Following Repeat Dose Administration (Part B) | Days 1 and 7 (pre-dose), Day 14 (24 hours) | All Subject Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Abnormal Nurse/Physician Observation (Part A) | Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | All Subject Population | ||
| PRIMARY | Number of Participants With Abnormal Nurse/Physician Observation (Part B) | Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose]) | All Subject Population | ||
| PRIMARY | Number of Participants With Hematology Values Outside the Clinical Concern Range (Part A) | Day 1 (pre-dose) | All Subjects Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Hematology Data Outside the Clinical Concern Range (Part B) | Day 1 (pre-dose) | All Subjects Population | Participants | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group197
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) | Placebo HVT (Cohort 1) | AEs | 2 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) | A/B (Cohort 1) | AEs | 3 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) | Placebo DFU SD (Cohort 2, 3, 4) | AEs | 1 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) | C (Cohort 2) | AEs | 0 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) | D (Cohort 3) | AEs | 2 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) | E (Cohort 4) | AEs | 1 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) | Placebo HVT (Cohort 1) | SAEs | 0 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) | A/B (Cohort 1) | SAEs | 0 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) | Placebo DFU SD (Cohort 2, 3, 4) | SAEs | 0 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A) | C (Cohort 2) | SAEs | 0 | Participants |
1 to 10 of 197Source ClinicalTrials.gov
See all 197 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo HVT (Cohort 1) | 4 | |
| Overall Study | STARTED | Placebo DFU SD (Cohort 2, 3, 4) | 3 | |
| Overall Study | STARTED | A/B (Cohort 1) | 9 | |
| Overall Study | STARTED | C/C (Cohort 2) | 5 | |
| Overall Study | STARTED | D (Cohort 3) | 5 | |
| Overall Study | STARTED | E/E (Cohort 4) | 3 | |
| Overall Study | STARTED | Placebo DFU RD (Cohort 5) | 4 | |
| Overall Study | STARTED | R1r (Cohort 5) | 26 | |
| Overall Study | STARTED | Sr (Cohort 5) | 4 | |
| Overall Study | COMPLETED | Placebo HVT (Cohort 1) | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events63
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Infected skin ulcer | Infections and infestations | Placebo HVT (Cohort 1) | 0 | 4 | 0 |
| other | Infected skin ulcer | Infections and infestations | A/B (Cohort 1) | 0 | 9 | 0 |
| other | Infected skin ulcer | Infections and infestations | Placebo DFU SD (Cohort 2, 3, 4) | 0 | 3 | 0 |
| other | Infected skin ulcer | Infections and infestations | C (Cohort 2) | 0 | 5 | 0 |
| other | Infected skin ulcer | Infections and infestations | D (Cohort 3) | 0 | 5 | 0 |
| other | Infected skin ulcer | Infections and infestations | E (Cohort 4) | 0 | 3 | 0 |
| other | Infected skin ulcer | Infections and infestations | Placebo DFU RD (Cohort 5) | 1 | 4 | 1 |
| other | Infected skin ulcer | Infections and infestations | R1r (Cohort 5) | 0 | 26 | 0 |
| other | Infected skin ulcer | Infections and infestations | Sr (Cohort 5) | 1 | 4 | 1 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Placebo HVT (Cohort 1) | 0 | 4 | 0 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo HVT (Cohort 1) | 0 | 4 |
| Total, all-cause mortality | A/B (Cohort 1) | 0 | 9 |
| Total, all-cause mortality | Placebo DFU SD (Cohort 2, 3, 4) | 0 | 3 |
| Total, all-cause mortality | C (Cohort 2) | 0 | 5 |
| Total, all-cause mortality | D (Cohort 3) | 0 | 5 |
| Total, all-cause mortality | E (Cohort 4) | 0 | 3 |
| Total, all-cause mortality | Placebo DFU RD (Cohort 5) | 0 | 4 |
| Total, all-cause mortality | R1r (Cohort 5) | 0 | 26 |
| Total, all-cause mortality | Sr (Cohort 5) | 0 | 4 |
| Total, other adverse events | Placebo HVT (Cohort 1) | 1 | 4 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30720931 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01831804
GET https://conductscience.org/api/trials/v1/NCT01831804/registered?page=2