Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Cohort 1 (Moderate hepatic impairment subjects) | Experimental | 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 |
|
| Part 1 Cohort 2 (Healthy control subjects) | Experimental | 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 |
|
| Part 2 Cohort 3 (Mild hepatic impairment subjects) | Experimental | 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 |
|
| Part 2 Cohort 4 (Healthy control subjects) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1265744 30mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
Not provided
Inclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Lakewood | Colorado | 80228 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30811880 | Background | Shaik JSB, Ford SL, Lou Y, Zhang Z, Bakshi KK, Tenorio AR, Trezza C, Spreen WR, Patel P. A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Cabotegravir in Patients With Hepatic Impairment and Healthy Matched Controls. Clin Pharmacol Drug Dev. 2019 Jul;8(5):664-673. doi: 10.1002/cpdd.655. Epub 2019 Feb 27. |
Not provided
Not provided
IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
| ID | Term |
|---|---|
| C584914 | cabotegravir |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 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 | Up to Day 14 |
| Composite of Clinical laboratory parameters including hematology, and clinical chemistry | Assessment of Laboratory parameters will include hematology, and clinical chemistry | 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 | 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 | Up to Day 14 |
| Orlando |
| Florida |
| 32809 |
| United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55404 | United States |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |