Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMB new formulation · 1 trial · 1 indication
Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who provided PK parameter data.
Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis.
Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis.
Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis.
Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis.
Blood samples were collected at indicated time-points for PK analysis of AMB. PK parameters were calculated by standard non-compartmental analysis.
| Arm | Type | Description |
|---|---|---|
| AMB dispersed in water/AMB oral tablet/reference AMB | EXPERIMENTAL | Eligible participants will receive a single oral dose of 5 milligram (mg) AMB tablet dispersed in water during treatment period 1 followed by a single dose of 5 mg AMB oral tablet in treatment period 2. In treatment period 3, participants will receive a single oral dose of reference 5 mg AMB tablet. There will be a washout period of 7 days between doses in each treatment period. |
| AMB oral tablet/reference AMB/AMB dispersed in water | EXPERIMENTAL | Eligible participants will receive single dose of 5 mg AMB oral tablet during treatment period 1 followed by single dose of reference 5 mg AMB oral tablet in treatment period 2. In treatment period 3, participants will receive single dose of 5 mg AMB tablet dispersed in water. There will be a washout period of 7 days between doses in each treatment period. |
| Reference AMB/AMB dispersed in water/AMB oral tablet | EXPERIMENTAL | Eligible participants will receive single dose of reference 5 mg AMB oral tablet during treatment period 1 followed by single dose of 5 mg AMB tablet dispersed in water in treatment period 2. In treatment period 3 participants will receive single dose of 5 mg AMB oral tablet. There will be a washout period of 7 days between doses in each treatment period. |
| AMB dispersed in water/reference AMB/AMB oral tablet | EXPERIMENTAL | Eligible participants will receive single dose of 5 mg AMB tablet dispersed in water during treatment period 1 followed by single dose of reference 5 mg AMB oral tablet in treatment period 2. In treatment period 3 participants will receive single dose of 5 mg AMB oral tablet. There will be a washout period of 7 days between doses in each treatment period. |
| AMB oral tablet/AMB dispersed in water/reference AMB | EXPERIMENTAL | Eligible participants will receive single dose of 5 mg AMB oral tablet during treatment period 1 followed by single dose of 5 mg AMB tablet dispersed in water in treatment period 2. In treatment period 3 participants will receive single dose of reference 5 mg AMB oral tablet. There will be a washout period of 7 days between doses in each treatment period. |
| Reference AMB/AMB oral/AMB dispersed in water | EXPERIMENTAL | Eligible participants in this arm will receive single dose of reference 5 mg AMB oral tablet during treatment period 1 followed by single dose of 5 mg AMB oral tablet in treatment period 2. In treatment period 3 participants will receive single dose of 5 mg AMB tablet dispersed in water There will be a washout period of 7 days between doses in each treatment period. |
| Name | Type | Description |
|---|---|---|
| AMB new formulation (1 mg) | DRUG | AMB tablets will be available at a unit dose strength of 1 mg. Participants will orally administer 5 tablets of 1 mg unit dose. |
| Reference AMB (5 mg) | DRUG | AMB reference tablet will be available as film-coated tablet at unit dose strength of 5 mg. Participants will orally administer 1 tablet of 5 mg unit dose |
Inclusion Criteria: * Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and cardiac monitoring. ...
AMB new formulation is an investigational small molecule developed by GSK plc for pulmonary hypertension. It is a lower dose formulation studied for relative bioavailability against marketed ambrisentan. The program is in Phase 1 development, with one completed trial conducted in healthy adult participants in the United Kingdom.
AMB new formulation is being developed for pulmonary hypertension, a cardiovascular condition. The only completed study evaluated its bioavailability in healthy adult volunteers rather than in patients with the disease, so its use in pulmonary hypertension remains investigational and has not been established through late-stage clinical testing.
AMB new formulation is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the Phase 1 relative bioavailability study of the lower dose ambrisentan formulation conducted in the United Kingdom.
AMB new formulation is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The study was a randomized, controlled relative bioavailability study of marketed and lower dose ambrisentan in healthy adult participants.
AMB new formulation has been studied in one completed Phase 1 trial, NCT04095286, titled Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants. The trial enrolled 29 healthy adults aged 18 years and older in the United Kingdom and used a randomized, controlled design.