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Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-0714 | Experimental | One time dosing in capsule formulation |
|
| Placebo | Placebo Comparator | Placebo comparator one time dosing in capsule formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-0714 | Drug | One time dosing in capsule formulation |
| |
| Placebo Comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of TD-0714 by assessing the number, severity and type of adverse events, including changes in vital signs, physical and neurological examinations, laboratory safety tests and ECGs | From Day 1 through end of study (Day 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of TD-0714 in plasma after a single-dose (SD): peak plasma concentration (Cmax) | Day 1 through end of study (Day 10) | |
| PK of TD-0714 in plasma after a SD: time to peak plasma concentration (Tmax) | Day 1 through end of study (Day 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics assessments for plasma atrial natriuretic peptide (ANP) concentrations | The day before dosing (Day -1) to the day after dosing (Day 2) | |
| Pharmacodynamics assessments for urine atrial natriuretic peptide (ANP) concentrations | The day before dosing (Day -1) to the day after dosing (Day 2) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Theravance Biopharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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| Drug |
One time dosing in capsule formulation |
|
| PK of TD-0714 in plasma after a SD: time to last measurable concentration (Tlast) | Day 1 through end of study (Day 10) |
| PK of TD-0714 in plasma after a SD: area under the plasma concentration vs. time curve from time zero to the last quantifiable concentration (AUC0-t) | Day 1 through end of study (Day 10) |
| PK of TD-0714 in plasma after a SD: area under the plasma concentration vs. time curve from time zero to 24 hours postdose (AUC0-24) | The day before dosing (Day -1) to the day after dosing (Day 2) |
| PK of TD-0714 in plasma after a SD: area under the plasma concentration vs. time curve from time zero to infinity (AUC0-∞) | Day 1 through end of study (Day 10) |
| PK of TD-0714 in plasma after a SD: CL/F (oral plasma clearance) | Day 1 through end of study (Day 10) |
| PK of TD-0714 in plasma after a SD: Vz/F (apparent volume of distribution during the terminal phase) | Day 1 through end of study (Day 10) |
| PK of TD-0714 in plasma after a SD: t1/2 (half-life) | Day 1 through end of study (Day 10) |
| PK of TD-0714 in urine after a SD: Ae (amount excreted in urine) | Day 1 through end of study (Day 10) |
| PK of TD-0714 in urine after a SD: Fe (fraction of oral dose excreted in urine) | Day 1 through end of study (Day 10) |
| PK of TD-0714 in urine after a SD: Clr (renal clearance) | Day 1 through end of study (Day 10) |
| Pharmacodynamics assessments for plasma cyclic guanosine monophosphate (cGMP) concentrations | The day before dosing (Day -1) to the day after dosing (Day 2) |
| Pharmacodynamics assessments for urine cyclic guanosine monophosphate (cGMP) concentrations | The day before dosing (Day -1) to the day after dosing (Day 2) |