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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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This study is designed to estimate the two-way drug interaction between DCV and DTG as a drug interaction between DTG and DCV is expected to be low and this study is to be performed as confirmation. This will be a single-center, open-label, three-period, crossover study in healthy adult subjects. This study to describe and compare steady-state plasma DTG and DCV pharmacokinetics following administration of DTG 50 mg q24h with and without DCV 60 mg q24h and following administration of DCV 60 mg q24h with and without DTG 50 mg q24h also the safety and tolerability was assessed after a repeat dose DTG 50 mg q24h with or without DCV 60 mg q24h and after a repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Participants will receive the study Treatment A for 5 days (DTG 50mg q24h) in Period 1 followed by a washout period (>=7days) and Treatment B for 5 days (DCV 60mg q24h) in Period 2 and Treatment C (DCV 60mg q24h + DTG 50mg q24h) for 5 days in Period 3 |
|
| Sequence 2 | Experimental | Participants will receive the study Treatment B for 5 days (DCV 60mg q24h) in Period 1 followed by a washout period (>=7days) and Treatment A for 5 days (DTG 50mg q24h) in Period 2 and Treatment C (DCV 60mg q24h + DTG 50mg q24h) for 5 days in Period 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTG | Drug | DTG is provided as 9 millimetre white, film-coated, round tablets debossed with SV 572 on one side and 50 on the other side |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of PK parameters of DTG following DTG 50 mg q24h administration with and without DCV 60mg q24h | Plasma PK parameters for DTG include steady state area under the concentration-time curve over the dosing interval (AUC (0-tau)), maximum observed concentration (Cmax), concentration at the end of the dosing interval (Ctau), apparent clearance following oral dosing (CL/F) and terminal phase half-life (t1/2) , following DTG 50 mg q24h administration with and without DCV 60mg q24h | Day 5 in Period 1 or 2, and Period 3: pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 8, 12 and 24 hours post morning dose |
| Composite of PK parameters of DCV following administration of DCV 60 mg q24h with and without DTG 50 mg q24h | Plasma DCV steady state AUC(0-tau), Cmax, Ctau, CL/F and t1/2 following administration of DCV 60 mg q24h with and without DTG 50 mg q24h | Day 5 (Periods 1 or 2, and Period 3): pre-dose (within 15 minutes prior to dosing), 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24hrs post morning dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of DTG and DCV as assessed by adverse event | Safety and tolerability of repeat dose DTG 50 mg q24h with or without DCV 60 mg q24h and repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h will be assessed by adverse events | Up to 36 days |
| Safety and Tolerability of DTG and DCV as assessed by concurrent medication |
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Inclusion Criteria:
Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy or postmenopausal defined as 12 months of spontaneous amenorrhea in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 milli international unit/mL and estradiol <40 picogram/mL (<147 picomolar/L) is confirmatory.
Child-bearing potential with negative pregnancy test as determined by serum or urine hCG test at screening or prior to dosing AND Agrees to use the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 72 hours post the last dose.
OR has only same-sex partners, when this is her preferred and usual lifestyle.
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 | Overland Park | Kansas | 66211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27450277 | Derived | Ross LL, Song IH, Arya N, Choukour M, Zong J, Huang SP, Eley T, Wynne B, Buchanan AM. No clinically significant pharmacokinetic interactions between dolutegravir and daclatasvir in healthy adult subjects. BMC Infect Dis. 2016 Jul 22;16:347. doi: 10.1186/s12879-016-1629-5. |
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| 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 |
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| DCV | Drug | DCV is provided as a plain, green, biconvex, pentagonal film-coated tablet |
|
Safety and tolerability of repeat dose DTG 50 mg q24h with or without DCV 60 mg q24h and repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h will be assessed by concurrent medication |
| Up to 36 days |
| Safety and Tolerability of DTG and DCV as assessed by clinical laboratory | Safety and tolerability of repeat dose DTG 50 mg q24h with or without DCV 60 mg q24h and repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h will be assessed by clinical laboratory | Up to 36 days |
| Safety and Tolerability of DTG and DCV as assessed by ECG | Safety and tolerability of repeat dose DTG 50 mg q24h with or without DCV 60 mg q24h and repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h will be assessed by ECG | Screening |
| Safety and Tolerability of DTG and DCV as assessed by vital signs assessments | Safety and tolerability of repeat dose DTG 50 mg q24h with or without DCV 60 mg q24h and repeat dose DCV 60 mg q24h with and without DTG 50 mg q24h will be assessed by vital signs assessments (blood pressure and heart rate) | Up to 36 days |
| 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 |