Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
D1400147 · 1 trial · 4 indications
To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for EPA on baseline subtracted plasma concentrations.
To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for DHA on baseline subtracted plasma concentrations.
To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.
To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for EPA on baseline subtracted plasma concentrations.
To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for DHA on baseline subtracted plasma concentrations.
To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.
To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for EPA on baseline subtracted plasma concentrations.
To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for DHA on baseline subtracted plasma concentrations.
To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.
| Arm | Type | Description |
|---|---|---|
| Part 1: Treatment A-B-C-D | EXPERIMENTAL | Subjects received a single dose of D1400147 (Treatment A: Omega-3-carboxylic acids 2000 mg uncoated capsules), D14000136 (Treatment B: Omega-3-carboxylic acids 2000 mg coated capsules coat 1), D14000137 (Treatment C: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) and Epanova® (Treatment D: Epanova capsules 1000 mg) under fasted condition. |
| Part 2: Treatment A-B/C-D | EXPERIMENTAL | Subjects received a single dose of D1400147 (Treatment A: Omega-3-carboxylic acids 2000 mg uncoated capsules), D14000136 (Treatment B: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) or D14000137 (Treatment C: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) and Epanova® (Treatment D: Epanova capsules 1000 mg) under fed condition. |
| Name | Type | Description |
|---|---|---|
| D1400147 | DRUG | Treatment A |
| D14000136 | DRUG | Treatment B |
| D14000137 | DRUG | Treatment C |
| Epanova® | DRUG | Treatment D |
Inclusion Criteria: * Provision of signed and dated written informed consent prior to any study specific procedures. * Healthy male and female (non-childbearing potential) subjects aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture. * Females must have a negative pregn...
D1400147 is an investigational small molecule being developed by AstraZeneca PLC (AZN). It is currently in Phase 1 clinical development for the assessment of relative bioavailability, specifically comparing the concentrations of omega-3 fatty acids EPA and DHA in blood when delivered as new capsules versus the Epanova capsule.
D1400147 is being studied to evaluate the relative bioavailability of omega-3 fatty acids EPA and DHA in healthy subjects. The Phase 1 trial compares the blood concentrations of these fatty acids when delivered as three new capsule formulations in relation to the Epanova capsule, under both fasting and fed conditions.
D1400147 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting a Phase 1 clinical trial to assess the relative bioavailability of this investigational small molecule.
D1400147 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its pharmacokinetics and relative bioavailability in healthy subjects.
D1400147 has one completed Phase 1 clinical trial registered under NCT02359045. This study, conducted in the United States, enrolled 137 healthy male subjects aged 18 years and older to compare the concentrations of omega-3 fatty acids EPA and DHA in blood when delivered as three new capsules in relation to the Epanova capsule under fasting and fed conditions.
No, D1400147 is not the same as Epanova. D1400147 is an investigational drug being developed by AstraZeneca, while Epanova is a reference capsule used in the clinical trial to compare the relative bioavailability of omega-3 fatty acids. The study evaluates how D1400147 formulations perform in relation to Epanova.