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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03921723 | Dolutegravir Pediatric Liquid Formulation Study | PHASE1 | COMPLETED | 22 | — | — | May 7, 2019 | Jul 25, 2019 | Jul 31, 2020 | 1 | United Kingdom |
Blood samples were collected at indicated time points and pharmacokinetic (PK) analysis was performed. PK parameters were determined by non-compartmental methods.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.
Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods.
| Arm | Type | Description |
|---|---|---|
| Subject receiving Dolutegravir 10 mg | EXPERIMENTAL | Subject will receive a prototype equivalent to DTG 10 mg liquid formulation in period 1, a prototype equivalent to DTG 10 mg liquid formulation in period 2, a DTG 10 mg dispersible tablet in Period 3, each period will be separated by washout period of \>= 7 days, if required a prototype equivalent to DTG 10 mg liquid formulation in period 4, a prototype equivalent to DTG 10 mg liquid formulation in period 5, and a prototype equivalent to DTG 10 mg liquid formulation in period 6 will be evaluated. |
| Name | Type | Description |
|---|---|---|
| Dolutegravir dispersible tablet | DRUG | DTG will be available as an oral tablet with dosing strength of 5 mg 2 tablet will be dispersed in water will be administered orally for prescribed regimen. |
| Dolutegravir oral suspension | DRUG | DTG will be available as an oral suspension with dosing strength of 5 mg per milliliter (ml) or 2 mg per ml with miglyol 812N or ethyl cellulose in miglyol 812N as vehicle for suspension administered orally for prescribed regimen. |
| Dolutegravir oral solution | DRUG | DTG will be available as an oral solution with dosing strength of 2 mg per ml will be administered orally for prescribed regimen. |
Inclusion Criteria: * Subject must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac evaluation. * Body weight \>= 50 ...