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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02185300 | Bioavailability Study of a Dolutegravir Dispersible Tablet and Effect of Different Types of Water on the Dispersible Tablet in Healthy Volunteers | PHASE1 | COMPLETED | 15 | — | — | Jul 1, 2014 | Sep 1, 2014 | Dec 2, 2014 | 1 | United States |
PK parameters include area under the concentration-time curve from time zero extrapolated to infinite time (AUC \[0-infinity\]) Maximum observed concentration (Cmax) and apparent oral clearance (CL/F)
PK parameters include AUC (0-infinity), Cmax and CL/F
PK parameters include AUC (0-infinity), Cmax and CL/F
| Arm | Type | Description |
|---|---|---|
| Sequence ABCDE | EXPERIMENTAL | Subject will be administered treatments in the sequence ABCDE where, A = Single dose of DTG 20 mg of the pediatric granule formulation reconstituted with purified water; B = Single dose of DTG 20 mg DT dispersed in LMC water; C = Single dose of DTG 20 mg DT dispersed in CONTREX mineral water; D= Single dose of DTG 20 mg DT dispersed in LMC water, held for 30 minutes(mins), re-dispersed, and then taken by subject; E = Single dose of DTG 20 mg DT dispersed in CONTREX mineral water, held for 30 minutes, re-dispersed, and then taken by subject |
| Sequence BCDEA | EXPERIMENTAL | Subject will be administered treatments in the sequence BCDEA where, A = Single dose of DTG 20 mg of the pediatric granule formulation reconstituted with purified water; B = Single dose of DTG 20 mg DT dispersed in LMC water; C = Single dose of DTG 20 mg DT dispersed in CONTREX mineral water; D= Single dose of DTG 20 mg DT dispersed in LMC water, held for 30 mins, re-dispersed, and then taken by subject; E = Single dose of DTG 20 mg DT dispersed in CONTREX mineral water, held for 30 mins, re-dispersed, and then taken by subject |
| Sequence CDEAB | EXPERIMENTAL | Subject will be administered treatments in the sequence CDEAB where, A = Single dose of DTG 20 mg of the pediatric granule formulation reconstituted with purified water; B = Single dose of DTG 20 mg DT dispersed in LMC water; C = Single dose of DTG 20 mg DT dispersed in CONTREX mineral water; D= Single dose of DTG 20 mg DT dispersed in LMC water, held for 30 mins, re-dispersed, and then taken by subject; E = Single dose of DTG 20 mg DT dispersed in CONTREX mineral water, held for 30 mins, re-dispersed, and then taken by subject |
| Sequence DEABC | EXPERIMENTAL | Subject will be administered treatments in the sequence DEABC where, A = Single dose of DTG 20 mg of the pediatric granule formulation reconstituted with purified water; B = Single dose of DTG 20 mg DT dispersed in LMC water; C = Single dose of DTG 20 mg DT dispersed in CONTREX mineral water; D= Single dose of DTG 20 mg DT dispersed in LMC water, held for 30 mins, re-dispersed, and then taken by subject; E = Single dose of DTG 20 mg DT dispersed in CONTREX mineral water, held for 30 mins, re-dispersed, and then taken by subject |
| Sequence EABCD | EXPERIMENTAL | Subject will be administered treatments in the sequence EABCD where, A = Single dose of DTG 20 mg of the pediatric granule formulation reconstituted with purified water; B = Single dose of DTG 20 mg DT dispersed in LMC water; C = Single dose of DTG 20 mg DT dispersed in CONTREX mineral water; D= Single dose of DTG 20 mg DT dispersed in LMC water, held for 30 mins, re-dispersed, and then taken by subject; E = Single dose of DTG 20 mg DT dispersed in CONTREX mineral water, held for 30 mins, re-dispersed, and then taken by subject |
| Name | Type | Description |
|---|---|---|
| Dolutegravir Pediatric Granules | DRUG | Dolutegravir pediatric granules are supplied as 40 grams bulk bottles containing 0.4% weight by weight of dolutegravir to be reconstituted with 73 mL of purified water to yield a dolutegravir concentration of 1.6 milligram / millilitre. 12.5 mL of reconstituted granules contain 20 mg DTG |
| Dolutegravir Dispersible Tablet | DRUG | Dolutegravir is available as 5mg dispersible tablets and can be administered as 4 tablets dispersed in 12.5 mL LMC water and consumed immediately or 4 tablets dispersed in 12.5 mL CONTREX mineral water and consumed immediately or 4 tablets dispersed in 12.5 mL LMC water, allow to stand at room temperature for 30 mins, re-suspend mixture and consumed or 4 tablets dispersed in 12.5 mL CONTREX mineral water, allow to stand at room temperature for 30 mins, re-suspend mixture and consumed |
Inclusion Criteria * Males or females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and c...