Trial · NCT01406340
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area under the concentration-time curve over the dosing interval . Composite of Pharmacokinetics | Blood samples will be collected at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72hr post dosing on Day 1 and Day 14 for normal and Stage3/4 subjects, and on Day 14 and Day 15 for Stage 5 subjects | Area under the concentration-time curve over the dosing interval of GSK1278863 and metabolites on Day 1 and Day 14 for normal subjects and subjects with Stage 3/4 renal function; Area under the concentration-time curve over the dosing interval of GSK1278863 and metabolites on Day 14 (dialysis) and Day 15 (non-dialysis) for subjects with Stage 5 renal function. |
| Primary | Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time. Composite of Pharmacokinetics | Blood samples will be collected at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72hr post dosing on Day 1 in normal and Stage3/4 subjects | Area under the concentration-time curve from time zero (pre-dose) of GSK1278863 and metabolites on Day 1 for normal subjects and subjects with Stage 3/4 renal functione-dose) extrapolated to infinite time for |
| Primary | Maximum observed concentration. Composite of Pharmacokinetics | Blood samples will be collected at predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 and 72hr post dosing on Day 1 and Day 14 for normal and Stage3/4 subjects, and on Day 14 and Day 15 for Stage 5 subjects | Maximum observed concentration of GSK1278863 and metabolites on Day 1 and Day 14 for normal subjects and subjects with Stage 3/4 renal function; Maximum observed concentration of GSK1278863 and metabolites on Day 14 and Day 15 for subjects with Stage 5 renal function. |
| Secondary | Safety and tolerability as assessed by the number of adverse events during the dosing period. | For normal subjects and subjects with Stage 3/4 renal function, from Day 1 to the follow-up visit at approximately Day 27. For subjects with Stage 5 renal function, from Day 1 to the follow-up visit at approximately Day 28. | |
| Secondary | Time of occurrence of maximum observed concentration | Day 1 and Day 14 | Time of occurrence of maximum observed concentration of GSK1278863 and metabolites on Day 1 and Day 14 for normal subjects and subjects with Stage 3/4 renal function |
| Secondary | Terminal phase half-life | Day 1 and Day 14 | Terminal phase half-life of GSK1278863 and metabolites on Day 1 and Day 14 for normal subjects and subjects with Stage 3/4 renal function |
| Secondary | renal clearance | Day 14 | renal clearance of GSK1278863 and metabolites in normal subjects and subjects with Stage 3/4 renal function |
| Secondary | dialysis clearance | Day 14 | dialysis clearance of GSK1278863 and metabolites in Stage 5 renal function |
| Secondary | change from baseline in QTcB or QTcF | For normal subjects and subjects with Stage 3/4 renal function, from Day 1 to Day 14; For subjects with Stage 5 renal function, from day 1 to day 15. | |
| Secondary | change from baseline in heart rate | For normal subjects and subjects with Stage 3/4 renal function, from Day 1 to the follow-up visit at approximately Day 27. For subjects with Stage 5 renal function, from Day 1 to the follow-up visit at approximately Day 28. | |
| Secondary | Safety and tolerability of GSK1278863 as assessed by change from baseline in toxicity grading of clinical laboratory tests | For normal subjects and subjects with Stage 3/4 renal function, from Day 1 to Day 15; For subjects with Stage 5 renal function, from Day 1 to Day 16. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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