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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02322749 | A Study to Assess the Relative Bioavailability of Process Variants of Selumetinib in Healthy Male Volunteers | PHASE1 | COMPLETED | 48 | — | — | Feb 1, 2015 | Apr 1, 2015 | Aug 31, 2016 | 1 | United Kingdom |
The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the maximum observed plasma concentration (Cmax) of selumetinib in healthy volunteers.
The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) of selumetinib in healthy volunteers.
The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC from time zero to the time of the last quantifiable concentration (AUC\[0-t\]) of selumetinib in healthy volunteers.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | AZD6244 blue reference capsules (3 x 25 mg) administered orally |
| Treatment B | EXPERIMENTAL | AZD6244 blue capsules (3 x 25 mg) Variant 1 (free base variant) administered orally |
| Treatment C | EXPERIMENTAL | AZD6244 blue capsules (3 x 25 mg) Variant 2 (vitamin E polyethylene glycol succinate \[TPGS\] variant) administered orally |
| Name | Type | Description |
|---|---|---|
| selumetinib 75mg single dose | DRUG | 3 blue capsules of 25 mg given as a single dose |
Inclusion Criteria:1.Provision of written informed consent 2.Healthy male volunteers aged 18 to 45 years 3.Calculated creatinine clearance (CrCL) \>50 mL/minute using the Cockcroft-Gault formula 4.Healthy volunteers with sexual partners who could become pregnant should agree to use 2 highly effectiv...