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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04210388 | A Study to Assess the Amount of Drug Levels in Blood and Safety of AZD5718 Formulations in Healthy Volunteers | PHASE1 | COMPLETED | 12 | — | — | Jan 14, 2020 | Mar 9, 2020 | Mar 25, 2020 | 1 | United Kingdom |
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
To evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation used in the ongoing Phase 2a clinical study (Reference treatment), in healthy volunteers
| Arm | Type | Description |
|---|---|---|
| AZD5718 tablet, Treatment A | EXPERIMENTAL | Volunteers will receive single doses of AZD5718 tablet, Formulation A under fasted conditions. |
| AZD5718 tablet, Treatment B | EXPERIMENTAL | Volunteers will receive single doses of AZD5718 tablet, Formulation B under fasted conditions. |
| AZD5718 tablet, Treatment C | EXPERIMENTAL | Volunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions. |
| AZD5718 tablet, Treatment D | EXPERIMENTAL | Volunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions. |
| AZD5718 film-coated tablet | ACTIVE_COMPARATOR | Volunteers will receive single doses of AZD5718 film-coated tablet, Reference treatment under fasted conditions. |
| Name | Type | Description |
|---|---|---|
| AZD5718 tablet, Formulation A | DRUG | Volunteers will receive single doses of AZD5718 tablet, Formulation A under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours. |
| AZD5718 tablet, Formulation B | DRUG | Volunteers will receive single doses of AZD5718 tablet, Formulation B under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours. |
| AZD5718 tablet, Formulation C | DRUG | Volunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours. |
| AZD5718 tablet, Formulation D | DRUG | Volunteers will receive single doses of AZD5718 tablet, Formulation D under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours. |
| AZD5718 film-coated tablet, Reference treatment | DRUG | Volunteers will receive single doses of AZD5718 film-coated tablet, Reference treatment under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours. |
Inclusion Criteria: For inclusion in the study volunteers should fulfill the following criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures. * Healthy male or female volunteers aged 18 to 55 years (inclusive at screening) with suitable veins fo...