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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02248818 | AZD8108 SAD/MAD in Healthy Volunteers | PHASE1 | COMPLETED | 258 | — | — | Nov 1, 2014 | Sep 1, 2015 | Apr 7, 2017 | 1 | United States |
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...