Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dolutegravir Pediatric Granules · 1 trial · 1 indication
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...
Dolutegravir Pediatric Granules is an investigational small molecule being developed for the treatment of Human Immunodeficiency Virus (HIV) infection. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Dolutegravir Pediatric Granules is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK.
Dolutegravir Pediatric Granules is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved for use outside of clinical trials. One Phase 1 trial has been completed.
Dolutegravir Pediatric Granules has one completed clinical trial, NCT02185300, a Phase 1 bioavailability study of a dolutegravir dispersible tablet in healthy volunteers in the United States. The study enrolled 15 participants aged 18 years and older.
Dolutegravir Pediatric Granules is a pediatric formulation of dolutegravir, an integrase inhibitor used to treat HIV. The pediatric granules are designed for administration to children, while the parent drug dolutegravir is available in other formulations for adults.