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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04827134 | A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants | PHASE1 | COMPLETED | 33 | — | — | May 7, 2021 | Jul 23, 2021 | Jun 5, 2023 | 1 | United States |
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG, ABC and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
Blood samples were collected at indicated time points for pharmacokinetic analysis of DTG and 3TC. The PK parameters were calculated by standard non-compartmental analysis.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: TRIUMEQ Fed followed by TRIUMEQ Fasted | EXPERIMENTAL | Participants received TRIUMEQ (dolutegravir \[DTG\] 5 milligram \[mg\]/abacavir \[ABC\] 60 mg/lamivudine \[3TC\] 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment A) in treatment period 1 followed by TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment B) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2. |
| Cohort 1: TRIUMEQ Fasted followed by TRIUMEQ Fed | EXPERIMENTAL | Participants received TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment B) in treatment period 1 followed by TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment A) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2. |
| Cohort 2: DOVATO Fed followed by DOVATO Fasted | EXPERIMENTAL | Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment C) in treatment period 1 followed by DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment D) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2. |
| Cohort 2: DOVATO Fasted followed by DOVATO Fed | EXPERIMENTAL | Participants received DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion under fasted conditions (Treatment D) in treatment period 1 followed by DOVATO (DTG 5 mg/3TC 30 mg), dispersible tablets administered as a dispersion immediately after a high calorie meal (under fed condition) (Treatment C) in treatment period 2. The treatment periods were separated by a washout period of about 7 days. All participants were followed-up for 7 to 14 days of last dose in treatment period 2. |
| Name | Type | Description |
|---|---|---|
| TRIUMEQ | DRUG | TRIUMEQ will be available as fixed dose combination (FDC) dispersible tablets to be administered orally as a dispersion. |
| DOVATO | DRUG | DOVATO will be available as FDC dispersible tablets to be administered orally as a dispersion. |
Inclusion Criteria: * Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent. * Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, lab...