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This is a two-part study. Part 1 will evaluate relative bioavailability of temsavir (TMR) following single dose administration of the reference fostemsavir (FTR) compared to two low-dose ER tablet formulations of FTR. In Part 2, the effect of food on the bioavailability of TMR will be assessed on the selected low-dose ER tablet formulation from Part 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Treatment sequence ABC | Experimental | Participants will receive FTR 3×200 mg ER tablets (Treatment A) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 2 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 3. |
|
| Part 1: Treatment sequence BCA | Experimental | Participants will receive FTR 3×200 mg ER tablets (Treatment B) in Period 1 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 3. |
|
| Part 1: Treatment sequence CAB | Experimental | Participants will receive FTR 600 mg ER tablet in Period 1 (Treatment C, reference) followed by FTR 3×200 mg ER tablets (Treatment A) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 3. |
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| Part 1: Treatment sequence ACB | Experimental | Participants will receive FTR 3×200 mg ER tablets (Treatment A) in Period 1 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fostemsavir 600 mg | Drug | Fostemsavir tablets will be administered via oral route. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area under the plasma concentration-time curve (AUC) from time zero to the last quantifiable time point (AUC[0-t]) of temsavir | Predose (Day 1) until 72 hour post dose | |
| Part 1: AUC from time zero extrapolated to infinite time (AUC[0-infinity]) of temsavir | Predose (Day 1) until 72 hour post dose | |
| Part 1: Maximum observed plasma concentration (Cmax) | Predose (Day 1) until 72 hour post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Time to Cmax (Tmax) of temsavir | Predose (Day 1) until 72 hour post dose | |
| Part 1: Elimination half-life (T1/2) of temsavir | Predose (Day 1) until 72 hour post dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Austin | Texas | 78744 | United States |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
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.
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C576364 | fostemsavir |
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This is a two-part study, where Part 1 will be conducted as a randomized three period, three treatment crossover study and Part 2 will have a randomized two period, two treatment crossover design.
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This is an open-label study
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| Part 1: Treatment sequence BAC |
| Experimental |
Participants will receive FTR 3×200 mg ER tablets (Treatment B) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 2 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 3. |
|
| Part 1: Treatment sequence CBA | Experimental | Participants will receive FTR 600 mg ER tablet (Treatment C, reference) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 3. |
|
| Part 2: Treatment sequence DE | Experimental | Participants will receive the selected low-dose formulation of FTR 3 × 200 mg ER tablets in a fasted state (Treatment D) in Period 1 and following a high fat high calorie meal (Treatment E) in Period 2. |
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| Part 2: Treatment sequence ED | Experimental | Participants will receive the selected low-dose formulation of FTR 3 × 200 mg ER tablets following a high fat high calorie meal (Treatment E) in Period 1 and in a fasted state (Treatment D) in Period 2. |
|
| Fostemsavir 200 mg | Drug | Fostemsavir tablets will be administered via oral route. |
|
| Part 1: Concentration at 12 hours post-dose of temsavir |
| 12 hours post-dose |
| Part 1 and Part 2: Number of participants with clinically significant change from Baseline in vital signs and clinical laboratory parameters | Baseline (Day -1) until end of follow up at 4 weeks |
| Part 1 and Part 2: Number of participants reporting adverse events (AEs) and serious adverse events (SAEs) | Baseline (Day -1) until end of follow up at 4 weeks |
| Part 2: AUC [0-t] of temsavir | Predose (Day 1) until 72 hour post dose |
| Part 2: AUC [0-infinity] of temsavir | Predose (Day 1) until 72 hour post dose |
| Part 2: Cmax of temsavir | Predose (Day 1) until 72 hour post dose |
| 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 |