Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD0585 · 2 trials · 2 indications
To demonstrate the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) in Japanese patients with hypertriglyceridemia.
To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia.
To investigate the effect of food timing on PK (area under the plasma concentration-time curve from time zero to infinity \[AUC\]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total eicosapentaenoic acid (EPA) and total docosahexaenoic acid (DHA), and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal).
To investigate the effect of food timing on PK (maximum plasma concentration \[Cmax\]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total EPA and total DHA, and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal). Analyses of the outcome measures presented are for baseline-adjusted data for total EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation. The geometric mean was calculated as the exponential of the arithmetic mean calculated from data on a log scale.
To investigate the effect of food timing on PK (area under the plasma concentration-time curve from time zero to 72 hours \[AUC0-72\]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total EPA and total DHA, and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal). Analyses of the outcome measures presented are for baseline-adjusted data for total EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation. The geometric mean was calculated as the exponential of the arithmetic mean calculated from data on a log scale.
| Arm | Type | Description |
|---|---|---|
| AZD0585 2g group | EXPERIMENTAL | AZD0585 1g × 2 capsules and AZD0585 placebo 1g × 2 capsules once daily |
| AZD0585 4g group | EXPERIMENTAL | AZD0585 1g × 4 capsules once daily |
| Placebo control group | PLACEBO_COMPARATOR | AZD0585 placebo 1g × 4 capsules once daily |
| Fasting | EXPERIMENTAL | Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered at the end of a 10-hour fast. |
| Before meal | EXPERIMENTAL | Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake). |
| After meal | EXPERIMENTAL | Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake). |
| Name | Type | Description |
|---|---|---|
| AZD0585 | DRUG | 1g soft capsule |
| AZD0585 placebo | DRUG | 1g soft capsule |
Key Inclusion Criteria: * Japanese men or women, ≥20 years of age. * Subjects must meet all of the following criteria; 1. Fasting triglyceride level: average of Visit 2 and Visit 3 must be in the range 150 - 499 mg/dL 2. %TG change between Visit 2 and Visit 3 must be within 30% 3. %LDL-C cha...
AZD0585 is an investigational small molecule being studied for hypertriglyceridemia, a condition of elevated triglycerides in the blood. It has also been evaluated in healthy volunteers to assess its pharmacokinetics. The drug is in clinical development by AstraZeneca and is not yet approved.
AZD0585 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials of AZD0585 in Japan, focusing on hypertriglyceridemia and healthy volunteer studies.
AZD0585 is in Phase 1 clinical development. While one completed trial was listed as Phase 3, the overall development stage is Phase 1, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing clinical evaluation.
AZD0585 has been studied in two completed trials. NCT02372344 was a Phase 1 study in healthy Japanese male subjects to investigate the effect of food on the pharmacokinetics of total EPA and DHA. NCT02463071 was a Phase 3 long-term study in Japanese patients with hypertriglyceridemia.
AZD0585 is a small molecule that appears to be related to eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), as a clinical trial measured the pharmacokinetics of total EPA and DHA after administration. However, AZD0585 is a distinct investigational drug being developed by AstraZeneca.