Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dolutegravir dispersible · 1 trial · 1 indication
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 ...
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Dolutegravir dispersible is a small molecule being developed for the treatment of HIV Infections. It is an investigational drug currently in Phase 1 clinical development. The dispersible formulation is designed for pediatric use, as indicated by the ongoing clinical trial studying this liquid formulation in the United Kingdom.
Dolutegravir dispersible is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical research on this investigational small molecule for the treatment of HIV Infections. The drug is currently in Phase 1 development.
Dolutegravir dispersible 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, involving 22 participants in the United Kingdom.
Dolutegravir dispersible has one completed clinical trial, NCT03921723, titled "Dolutegravir Pediatric Liquid Formulation Study." This Phase 1 study enrolled 22 participants with HIV Infections in the United Kingdom. The trial was uncontrolled, not randomized, and not double-blinded, and it included healthy volunteers.
Dolutegravir dispersible is a formulation of the drug dolutegravir, specifically designed as a dispersible or liquid formulation for pediatric use. While the active ingredient is the same, the dispersible version is being studied separately in clinical trials for its suitability in treating HIV Infections in younger populations.