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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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A single dose escalation study to determine the safety, tolerability, and pharmacokinetic profile of intramuscular and subcutaneous injections of GSK1265744 long acting parenteral (LAP) in healthy subjects. This study consists of a screening visit, a single injection, and follow-up evaluations for a minimum of 12 weeks following the injection.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 100 mg GSK1265744 injectable suspension or placebo, intramuscular dosing |
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| Cohort 2 | Experimental | 200 mg GSK1265744 injectable suspension or placebo, intramuscular dosing |
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| Cohort 3 | Experimental | 400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing |
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| Cohort 4 | Experimental | 800 mg GSK1265744 injectable suspension or placebo, intramuscular dosing |
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| Cohort 5 | Experimental | 100 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1265744 injectable suspension | Drug | 200 milligram per milliliter sterile solution for injection |
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| Measure | Description | Time Frame |
|---|---|---|
| GSK1265744 safety and tolerability parameters including: the collection of adverse events | 12 weeks | |
| Change from baseline values in clinical laboratory assessments | 12 weeks | |
| Change from baseline for Electrocardiogram (ECG) assessments | 12 weeks | |
| Change from baseline valuse in vital sign assessments (systolic and diastolic blood pressure and pulse rate) | 12 weeks | |
| Composite of pharmacokinetic parameters: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks | GSK1265744 pharmacokinetic parameters: area under the plasma concentration time curve from time zero to the last quantifiable time points (AUC(0-tau)), area under the plasma concentration time curve from time zero to infinity (AUC(0-infinity)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), apparent terminal phase half-life for LAP administration (t½), lambda z as a measure of absorption rate constant | 12 weeks |
| GSK1265744 concentration at 1 month post-dose (C720 hours) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetic parameters: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks. | GSK1265744 pharmacokinetic parameters: absorption lag time (tlag), apparent clearance (CL/F,LAP) following single dose administration, Percentage of AUC(0-infinity) obtained by extrapolation (AUC%ex) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
An average weekly intake of greater than 14 drinks for males or greater than 7 drinks for females.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
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| Cohort 6 | Experimental | 200 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing |
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| Cohort 7 | Experimental | 400 mg GSK1265744 injectable suspension or placebo, subcutaneous dosing |
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| Cohort 8 | Experimental | 400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing |
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| Cohort 9 | Experimental | 400 mg GSK1265744 injectable suspension or placebo, intramuscular dosing |
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| Placebo to match injectable suspension | Other | placebo |
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| Composite of pharmacokinetic parameters for dose proportionality: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks | GSK1265744 following single dose administration at different doses for the assessment of dose proportionality: AUC(0-infinity), AUC(0-tau), Cmax | 12 weeks |
| GSK1265744 C720 hours following single dose administration at different doses for the assessment of dose proportionality | 12 weeks |
| GSK1265744 concentrations in cervicovaginal fluid (CVF), cervical tissue (CT), vaginal tissue (VT), rectal tissue (RT), and blood plasma and ratio of CVF, CT, VT, and RT concentration to blood plasma | Cohort 8 at week 2 and week 8; Cohort 9 at week 4 and week 12 | Cohort 8 at week 2 and week 8; Cohort 9 at week 4 and week 12 |
| ID | Term |
|---|---|
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C584914 | cabotegravir |
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