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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01702493 | A Study to Assess the Relative Bioavailability of New Oral Formulations of SRT2104 in Healthy Male Volunteers | PHASE1 | COMPLETED | 16 | — | — | Oct 30, 2012 | Dec 5, 2012 | Jun 12, 2017 | 1 | United States |
The variability in exposure of SRT2104 will be assessed by calculating the within subject coefficient of variation (CVw).
Relative bioavailability of SRT2104 will be assessed by evaluating area under the curve (AUC).
Relative bioavailability of SRT2104 will be assessed by measuring maximum observed plasma concentration (Cmax).
Relative bioavailability of SRT2104 will be assessed by measuring the time to reach maximum observed plasma concentration (Tmax).
Safety parameter will include recording number of AEs, throughout the study.
Safety parameter will include recording of intensity of AEs, throughout the study.
Safety parameter will include recording of type of AEs, throughout the study.
Safety will be assessed by recording heart rate at Baseline and at end of the study.
Safety will be assessed by recording blood pressure at Baseline and at end of the study.
Safety will be assessed by recording temperature at Baseline and at end of the study.
Safety will be assessed by recording the electrocardiogram (ECG) readings at Baseline and at end of the study.
Clinical laboratory parameters will include hematology, clinical chemistry and electrolytes, serology, coagulation and urinalysis. Safety will be assessed by evaluating the clinical laboratory parameter readings at Baseline and at end of the study.
| Arm | Type | Description |
|---|---|---|
| Part 1: Cap SRT2104 | ACTIVE_COMPARATOR | 500 mg SRT2104 (in the form of two, 250 mg capsules) will be administered as a single oral dose in the fasting state |
| Part 1: Tab SRT2104 (slow release) | EXPERIMENTAL | 500 mg SRT2104 (in the form of two, 250 mg slow release tablets) will be administered as a single oral dose in the fasting state. |
| Part 1: Tab SRT2104 (intermediate release) | EXPERIMENTAL | 500 mg SRT2104 (in the form of two, 250 mg intermediate release tablets) will be administered as a single oral dose in the fasting state. |
| Part 1: Tab SRT2104 (fast release) | EXPERIMENTAL | 500 mg SRT2104 (in the form of two, 250 mg fast release tablets) will be administered as a single oral dose in the fasting state. |
| Part 2A: SRT2104 500 mg single-dose | EXPERIMENTAL | 500 mg SRT2104 (formulation selected from Part 1) will be administered as a single oral dose in the fed state. |
| Part 2B: SRT2104 single alternative dose | EXPERIMENTAL | An alternative dose (other than 500 mg, but not to exceed 2000 mg) of SRT2104 (formulation selected from Part 1) will be administered as a single oral dose. |
| Part 2C: SRT2104 500 mg daily for 7 days | EXPERIMENTAL | 500 mg SRT2104 (formulation selected from Part 1) will be administered daily for 7 days. |
| Name | Type | Description |
|---|---|---|
| Cap SRT2104 | DRUG | Micronized free base in a 250 mg SRT2104 (active equivalents) capsule |
| Tab SRT2104 slow release | DRUG | New 250 mg SRT2104 mesylate salt slow release tablet |
| Tab SRT2104 intermediate release | DRUG | New 250 mg SRT2104 mesylate salt intermediate release tablet |
| Tab SRT2104 fast release | DRUG | New 250 mg SRT2104 mesylate salt fast release tablet |
| Selected formulations of SRT2104 from Part 1 | DRUG | SRT2104 500 mg of selected formulation(s) from Part 1 in single-dose or daily for 7 days |
| Selected formulations of SRT2104 from Part 1 single alternative dose | DRUG | SRT2104 single alternative dose (other than 500 mg, but not to exceed 2000 mg) of selected formulation(s) from Part 1 |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician. * Males between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Body weight \>=50 kilogram (kg) (110 lbs) and body mass index (BMI) \>=18. * Capable of giving written informed co...