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| Name | Class |
|---|---|
| Shionogi | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
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To evaluate the single dose relative bioavailability of GSK1265744 10mg administered in either oral solution fasted, two 5mg tablets fasted, or two 5mg tablets following a moderate meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | GSK1265744 10mg oral solution |
|
| Treatment B | Experimental | GSK1265744 5mg tablet, fasted |
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| Treatment C | Experimental | GSK1265744 5mg tablet, fed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1265744 10 mg oral solution | Drug | GSK1265744 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetic parameters | Plasma GSK1265744 Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)], Area under the concentration-time curve over the dosing interval [AUC(0-t)], and Maximum observed concentration (Cmax). | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability parameters, including the collection adverse events | 6 days | |
| Composite of pharmacokinetic parameters | Plasma GSK1265744 Terminal phase half-life (t½), Lag time before observation of drug concentrations in sampled matrix (tlag), Time of occurrence of Cmax (tmax), and Apparent clearance following oral dosing (CL/F). |
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Inclusion Criteria:
Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Male or female between 18 and 55 years of age.
A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who:
A male is eligible to enter and participate in the study if he is surgically sterile OR if he either agrees to abstain from sexual intercourse with a female partner or agrees to use a condom/spermicide, in addition to having his female partner use another form of contraception as outlined in Section 7.1.
Body weight >= 50 kg (110 lbs.) for men and >= 45 kg (99 lbs) for women and body mass index (BMI) within the range 18.5-31.0 kg/m2 (inclusive).
A signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening.
Subject must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion Criteria:
Note: 1 drink is equivalent to 12 g alcohol = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
Note: This does not include plasma donation.
- History or presence of allergy or intolerance to the study drug or its components or drugs of its class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
Note: "Study" or "investigational" drugs include GSK1265744 or placebo.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Buffalo | New York | 14202 | United States |
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| GSK1265744 5 mg tablet | Drug | GSK1265744 5mg tablet, fasted |
|
|
| GSK1265744 5 mg tablet | Drug | GSK1265744 5mg tablet, fed |
|
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| 6 days |
| Safety and tolerability parameters including the change from baseline in clinical laboratory assessments | Clinical chemistry, hematology and urinalysis compared to baseline values | 6 days |
| Safety and tolerability parameters including the collection of concurrent medication | 6 days |
| Safety and tolerability parameters including the change from baseline in electrocardiogram values (ECG). | 6 days |
| Safety and tolerability parameters including change from baseline in vital sign measurements | blood pressure and heart rate | 6 days |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D007239 | Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| 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 |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| C584914 | cabotegravir |
| D012996 | Solutions |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D004304 | Dosage Forms |
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