Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD8108 · 1 trial · 1 indication
Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal
Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 after single/first dose of AZD8108
Pharmacokinetic : Area under the concentration curve (0 to 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 \& 7, Cohort 6 did not reach Day 6
Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 \& 7, Cohort 6 did not reach Day 12
Pharmacokinetic : Area under the concentration curve (0 to 24 hours), AZD6765 after Day 12 dose of AZD8108 cohort 5 \& 7, Cohort 6 dod not reach Day 12
Pharmacokinetic : Maximum concentration of AZD6765 after single/first dose of AZD8108
Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 6 dose of AZD8108, Cohorts 5 \& 7, Cohort 6 did not reach Day 6
Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 \& 7, Cohort 6 did not reach Day 12
| Arm | Type | Description |
|---|---|---|
| AZD8108 | EXPERIMENTAL | Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 6 subjects will receive AZD8108 |
| Placebo to match AZD8108 | PLACEBO_COMPARATOR | Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 2 subjects will receive matching placebo |
| Name | Type | Description |
|---|---|---|
| AZD8108 | DRUG | Drug: AZD8108 Single or Multiple doses administered orally as a solution. |
| Placebo | DRUG | Placebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution |
Inclusion Criteria: Inclusion Criteria: 1. Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-specific procedures. 2. Men and postmenopausal or surgically sterile women age 1...
AZD8108 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN). It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. The specific disease indications for which AZD8108 is being developed have not been publicly disclosed.
AZD8108 targets NMDA receptor subunits, specifically GRIN1, GRIN2A, GRIN2B, GRIN2C, GRIN2D, and GRIN3B. It acts as an antagonist at these targets. This mechanism of action is being explored in early clinical development.
AZD8108 is being developed by AstraZeneca PLC, which trades under the ticker symbol AZN. AstraZeneca is a global biopharmaceutical company headquartered in the United Kingdom.
AZD8108 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any regulatory authority. The Phase 1 trial has been completed.
AZD8108 has been evaluated in a single Phase 1 clinical trial, NCT02248818, titled 'AZD8108 SAD/MAD in Healthy Volunteers.' This completed trial enrolled 258 healthy adult participants in the United States and used a randomized, double-blind, placebo-controlled design.