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TRIUMEQ · 1 trial · 1 indication
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...
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TRIUMEQ is an investigational small molecule being studied for the treatment of HIV Infections. It is currently in Phase 1 clinical development. The drug is being evaluated in a food-effect study using pediatric dispersible tablet formulations in healthy adult participants.
TRIUMEQ is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate the drug for HIV Infections. As of the latest data, TRIUMEQ is in Phase 1 development.
TRIUMEQ is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, which studied the drug's food effect in healthy adult participants.
TRIUMEQ has one completed clinical trial, NCT04827134, titled "A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants." This Phase 1 study enrolled 33 participants in the United States and was a controlled, randomized trial.
TRIUMEQ and DOVATO are distinct drugs, but they were studied together in a clinical trial. The Phase 1 study NCT04827134 evaluated the food effect of both TRIUMEQ and DOVATO pediatric dispersible tablet formulations. Both are being developed by GSK plc for HIV Infections.