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This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD) study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD TD-6450 | Placebo Comparator | Single ascending dose (Part A) |
|
| MAD TD-6450 | Placebo Comparator | Multiple ascending dose (Part B) |
|
| Food effect of TD-6450 | Active Comparator | Food effect will be assessed in Part A (SAD) of this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-6450 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 28 days max |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Pharmacokinetics | 28 days max |
| Tmax | Pharmacokinetics | 28 days max |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Theravance Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Development Solutions | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37029122 | Derived | Carucci M, Duez J, Tarning J, Garcia-Barbazan I, Fricot-Monsinjon A, Sissoko A, Dumas L, Gamallo P, Beher B, Amireault P, Dussiot M, Dao M, Hull MV, McNamara CW, Roussel C, Ndour PA, Sanz LM, Gamo FJ, Buffet P. Safe drugs with high potential to block malaria transmission revealed by a spleen-mimetic screening. Nat Commun. 2023 Apr 7;14(1):1951. doi: 10.1038/s41467-023-37359-2. |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| Drug |
|
| AUC |
Pharmacokinetics |
| 28 days max |
| T1/2 | Pharmacokinetics | 28 days max |
| Food effect on AUC value | Measure difference between fasted and fed doses | 15 days max |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |