Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05489406 | Relative Bioavailability Study to Investigate a Potential Interaction Between DTG DT and F/TAF TOS. | PHASE1 | COMPLETED | 16 | — | — | Oct 6, 2022 | Nov 30, 2023 | Dec 6, 2023 | 1 | Netherlands |
The relative bioavailability of TAF and TFV after a single-dose F/TAF 180/22.5 mg as 3X60/7.5 mg TOS (reference TAF) compared to TAF and TFV after a single-dose F/TAF 180/22.5 mg as 3X60/7.5 mg TOS in combination with a single dose of DTG 30 mg as 6X5 mg DT tablets (test).
The relative bioavailability of FTC after a single-dose F/TAF 180/22.5 mg as 3X60/7.5 mg TOS (reference FTC) compared to FTC after a single-dose F/TAF 180/22.5 mg as 3X60/7.5 mg TOS in combination with a single dose of DTG 30 mg as 6X5 mg DT tablets (test).
The relative bioavailability of DTG after a single-dose DTG 30 mg as 6X 5 mg DT tablets (reference DTG) compared to DTG after a single-dose F/TAF 180/22.5 mg as 3X60/7.5 mg TOS in combination with a single dose of DTG 30 mg as 6X5 mg DT tablets (test).
The relative bioavailability of the potential interaction, the pharmacokinetics (AUC0-∞, Cmax, Tmax, T1⁄2) of DTG, FTC, TAF and TFV will be obtained and the geometric mean ratios of the AUC0-tlast (TAF), AUC0-∞ (DTG, FTC and TFV only), Cmax , and Cmin (DTG, FTC and TFV only) of the test versus reference treatment
| Arm | Type | Description |
|---|---|---|
| Single-dose DTG 30 mg | ACTIVE_COMPARATOR | Healthy volunteers receiving a single-dose DTG 30 mg as 6X5 mg dispersible tablets (DT) as a dispersed suspension in a fasted state. Samples will be taken pre-dose (t=0) and 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, and 48 hours post ingestion. |
| Single-dose F/TAF 180/22.5 mg | ACTIVE_COMPARATOR | Healthy volunteers receiving a single-dose F/TAF 180/22.5 mg as 3X60/7.5 mg TOS as a dispersed suspension in a fasted state. Samples will be taken pre-dose (t=0) and 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, and 48 hours post ingestion. |
| Single-dose DTG 30 mg and F/TAF 180/22.5 mg | EXPERIMENTAL | Healthy volunteers receiving a single-dose F/TAF 180/22.5 mg as 3X60/7.5 mg TOS + DTG 30 mg as 6X5 mg DT as a co-dispersed suspension in a fasted state. Samples will be taken pre-dose (t=0) and 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, and 48 hours post ingestion. |
| Name | Type | Description |
|---|---|---|
| DTG DT (6 x 5 mg) | DRUG | DTG 5mg dispersible tablet |
| F/TAF TOS (3 x 60/7.5 mg) | DRUG | 60/7.5 mg TOS emtricitabine/TAF |
Inclusion Criteria: 1. Subject is at least 18 and not older than 55 years of age at the day of screening. 2. Subject weighs at least 40 kg. 3. Subject has a BMI of 18.5-30 kg/m2, extremes included. 4. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. 5. S...