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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03420092 | A Study to Assess the Bioavailability of Different Formulations of AZD5718 and the Food Effect on the Selected Formulation of AZD5718 in Healthy Volunteers | PHASE1 | COMPLETED | 14 | — | — | Feb 5, 2018 | Apr 18, 2018 | Apr 23, 2018 | 1 | United Kingdom |
To assess the pharmacokinetics (PK) parameter AUC to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
To assess the PK parameter AUC(0-t)to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
To assess the PK parameter Cmax to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
To assess the PK parameter C24 to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | The participant will be administered with Form 1 of AZD5718 tablets with an overnight fast of at least 10 hours. |
| Treatment B | EXPERIMENTAL | The participant will be administered with Form 2 of AZD5718 tablets with an overnight fast of at least 10 hours. |
| Treatment C | EXPERIMENTAL | The participant will be administered with Form 3 of AZD5718 tablets with an overnight fast of at least 10 hours. |
| Treatment D | EXPERIMENTAL | The participant will be administered with Form 4 of AZD5718 tablets with an overnight fast of at least 10 hours. |
| Treatment E | EXPERIMENTAL | The participant will be administered with Form 5 of AZD5718 tablets with an overnight fast of at least 10 hours. |
| Treatment F | EXPERIMENTAL | The participant will be administered with selected form (one of Form 2-5) of AZD5718 tablets 30 minutes after start of the meal. |
| Name | Type | Description |
|---|---|---|
| Form 1 of AZD5718 tablets | DRUG | The participants will be dosed with Form 1 of AZD5718 following an overnight fast of at least 10 hours. |
| Form 2 of AZD5718 tablets | DRUG | The participants will be dosed with Form 2 of AZD5718 following an overnight fast of at least 10 hours. |
| Form 3 of AZD5718 tablets | DRUG | The participants will be dosed with Form 3 of AZD5718 following an overnight fast of at least 10 hours. |
| Form 4 of AZD5718 tablets | DRUG | The participants will be dosed with Form 4 of AZD5718 following an overnight fast of at least 10 hours. |
| Form 5 of AZD5718 tablets | DRUG | The participants will be dosed with Form 5 of AZD5718 following an overnight fast of at least 10 hours. |
| Selected form (Form 2 - 5) of AZD5718 tablets | DRUG | The participant will be administered with selected form (one of Form 2-5) of AZD5718 tablets 30 minutes after start of the meal. |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent before any study specific procedures. 2. Healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture. 3. Females must have a negative pregnancy test at...