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This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects.
This is a double-blind, randomized, placebo-controlled, multiple ascending dose escalation study of TT-00920 in healthy subjects. Each dosing cohort will be comprised of 10 randomized subjects dosed three times daily for 13 days and one time for 1 day. The study will consist of a Screening Period, an In-house Period and a Follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 (Low dose) | Active Comparator | TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14. |
|
| Dose 2 (High dose) | Active Comparator | TT-00920, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14. |
|
| Placebo | Placebo Comparator | TT-00920 Placebo, orally, three times daily (t.i.d.) from Day 1 to Day 13 and once on Day 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TT-00920 | Drug | TT-00920 Tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TEAEs and clinically relevant changes in safety parameters,e.g. clinical laboratory tests, 12-lead ECG, ophthalmological examination [Safety and tolerability] |
| 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration versus time curve at steady state (AUC0-t, ss and AUC0-Ï„, ss) | 14 days | |
| Maximum observed plasma concentration at steady state (Cmax, ss) | 14 days | |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolite characterization in plasma and estimation | observed drug-related material in plasma to determine the presence of any metabolite >10% | 14 days |
| Change in Biomarkers From Baseline to Day 14: cGMP (Pmol/mL) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaron CPC, Inc. | Baltimore | Maryland | 21201 | United States |
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| TT-00920 Placebo |
| Drug |
TT-00920 Placebo Tablets |
|
| Time corresponding to occurrence of Cmax,ss at steady state (Tmax, ss) |
| 14 days |
| Minimum observed plasma concentration at steady state (Cmin, ss) | 14 days |
| Trough plasma concentration (Ctrough) | 14 days |
| Accumulation ratio (Rac) | 14 days |
| Average concentration (Cav) | 14 days |
| Volume of distribution at steady state (Vz/F, ss) | 14 days |
| Clearance at steady state (CL/F, ss) | 14 days |
| Half-life at steady state (T1/2, ss) | 14 days |
cGMP: cyclic guanosine monophosphate
| 14 days |
| Utilization of PGx results | A pharmacogenomic (PGx) panel will be performed to test for genetic variations in genes related to drug response | 14 days |