Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single and multiple ascending dose study in healthy male and female (of non-child bearing potential) Japanese and White volunteers, to assess the safety, tolerability, and blood and urine drug levels of FosD. FosD is being developed for the treatment of rheumatoid arthritis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FosD | Experimental | Four sequential cohorts of Japanese subjects are planned with doses ranging from 50mg once daily to a maximum of 200mg twice daily. One cohort of White subjects is also planned to receive the same dose regimen as the third dose level in Japanese subjects |
|
| Placebo | Placebo Comparator | Placebo given (2 subjects in each cohort) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FosD | Drug | oral tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate safety and tolerability: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, 12 lead ECG, digital ECG, telemetry. | Prior to treatment, during treatment, and a follow-up visit, a total of up to 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| To determine plasma PK parameters (including but not limited to: AUC, tmax, Cmax, terminal elimination half life (t1/2) and accumulation ratio (Rac)) of FosD. | Plasma sampling for 72 hours following both the single dose and after 7 days repeated dosing. | |
| To determine urine PK parameters (including but not limited to: amount excreted (Ae) and renal clearance (CLr)) of FosD. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Layton, MD | AstraZeneca | Study Director |
| Mark Yen, MD | PAREXEL Early Phase/California Clinical Trials Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
oral tablet |
|
| Urine sampling for upto 48 hours following both the single dose and after 7 days repeated dosing. |