A Phase 1 interventional study of GSK1265744 30mg in HIV Infections, sponsored by ViiV Healthcare. Completed at 3 sites in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-05.
Sponsored by ViiV Healthcare · Phase 1, Interventional, and Treatment
This will be a Phase 1, open-label, parallel group, two-part, single-dose adaptive study in adults with moderate and mild (if needed) hepatic impairment and matched, healthy control subjects with normal hepatic function. In Part 1, healthy control subjects (n=8) matched to subjects with moderate (n=8) hepatic impairment will be enrolled. If the geometric mean total plasma area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) of GSK1265744 is increased by >2-fold in moderately impaired subjects relative to matched controls, Part 2 will be conducted to evaluate GSK1265744 PK in subjects with mild hepatic impairment (n=8) and matched, control subjects (n=8). All subjects will receive a single 30 milligram (mg) oral dose of GSK1265744. The primary objective of the study is to compare plasma PK parameters of GSK1265744 in subjects with hepatic impairment to healthy controls matched in gender, age, and body mass index (BMI).
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 16 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.
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Part 1 subjects with Moderate Hepatic Impairment Only (Cohort 1):
Part 2 subjects with Mild Hepatic Impairment Only (Cohort 3):
Inclusion Criteria for Healthy Subjects (Cohorts 2 and 4):
Exclusion Criteria:
Subjects with a history of peptic ulceration or pancreatitis within the preceding 6 months of screening should be excluded.
Subjects with moderate hepatic impairment will receive GSK1265744 30mg as a single oral dose in the fasted state followed by pharmacokinetic sampling for total concentrations of GSK1265744 in plasma
Drug: GSK1265744 30mg
Healthy control subjects will receive GSK1265744 30mg as a single oral dose in the fasted state followed by pharmacokinetic sampling for total concentrations of GSK1265744 in plasma
Drug: GSK1265744 30mg
Subjects with mild hepatic impairment will receive GSK1265744 30mg as a single oral dose in the fasted state followed by pharmacokinetic sampling for total concentrations of GSK1265744 in plasma
Drug: GSK1265744 30mg
Healthy control subjects will receive GSK1265744 30mg as a single oral dose in the fasted state followed by pharmacokinetic sampling for total concentrations of GSK1265744 in plasma
Drug: GSK1265744 30mg
GSK1265744 30mg tablets are white to almost white coated oval tablets. All subjects will receive GSK1265744 30mg as a single oral dose in the fasted state followed by PK sampling.
Plasma area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)] following a single oral dose of GSK1265744
Plasma PK samples (2 mL of blood per sample) will be collected to measure GSK1265744 at the following time points: pre-dose (within 15 minutes prior to dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose
Time frame: Pre-dose (within 15 minutes prior to dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose (Day 8)
Maximum observed concentration (Cmax) following a single oral dose of GSK1265744
Plasma PK samples (2 mL of blood per sample) will be collected to measure GSK1265744 at the following time points: pre-dose (within 15 minutes prior to dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose
Time frame: Pre-dose (within 15 minutes prior to dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose (Day 8)
Unbound concentration and unbound fraction in plasma of GSK1265744 at 2 and 24 hours post dose
Blood samples will be collected to measure bound and unbound plasma GSK1265744 concentrations at 2 and 24 hours post dose
Time frame: Up to 24 hours post dose (Day 2)
Composite of PK parameters including AUC(0-t), %AUCex, C24, t1/2, CL/F, tlag, tmax, and Vz/F following a single oral dose of GSK1265744
PK parameters including plasma area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration \[AUC(0-t)\], percentage of AUC(0-infinity) obtained by extrapolation (%AUCex), concentration observed at 24-hours post dose (C24), apparent terminal phase half-life (t1/2), apparent clearance (CL/F), lag time before observation of drug concentrations (tlag), time of occurrence of Cmax (tmax) and apparent terminal phase volume of distribution (Vz/F) following a single oral dose of GSK1265744
Time frame: Pre-dose (within 15 minutes prior to dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose (Day 8)
Adverse events (AEs) assessment
An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Time frame: Up to Day 14
Composite of Clinical laboratory parameters including hematology, and clinical chemistry
Assessment of Laboratory parameters will include hematology, and clinical chemistry
Time frame: Up to Day 14
Electrocardiogram (ECG) monitoring
12-lead ECGs will be performed with the subject in a semi-supine position having rested in this position for at least 10 minutes beforehand
Time frame: Up to Day 2
Composite of Vital signs assessments will include measurement of temperature, systolic and diastolic blood pressure, heart rate and respiratory rate
Vital signs will be measured in semi-supine position after 10 minutes rest and will include temperature, systolic and diastolic blood pressure (BP), heart rate (HR) and respiratory rate
Time frame: Up to Day 14
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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ViiV Healthcare