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This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy subjects and Part B is a multiple ascending dose (MAD) study in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD-5202 for SAD (Part A) | Experimental | 6 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive TD-5202 |
|
| Placebo for SAD (Part A) | Placebo Comparator | 2 out of 8 subjects per cohort (up to 4 cohorts) will be randomized to receive placebo |
|
| TD-5202 for MAD (Part B) | Experimental | 6 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive TD-5202 |
|
| Placebo for MAD (Part B) | Placebo Comparator | 2 out of 8 subjects per cohort (up to 3 cohorts) will be randomized to receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD-5202 | Drug | Study Drug to be administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of SAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events | Day 1 through Day 8 | |
| To assess the safety and tolerability of MAD of TD-5202 by assessing the number, severity and type of treatment emergent adverse events | Day 1 through Day 17 | |
| Pharmacokinetics (PK) of TD-5202 when given as an SAD: AUC | Area under the plasma concentration-time curve (AUC) | Day 1 through Day 4 |
| Pharmacokinetics (PK) of TD-5202 when given as a SAD: Cmax | Maximum observed concentration (Cmax) | Day 1 through Day 4 |
| Pharmacokinetics (PK) of TD-5202 when given as a SAD: Tmax | Time to reach maximum observed concentration (Tmax) | Day 1 through Day 4 |
| PK of TD-5202 when given as an SAD: CL/F | Oral Clearance (CL/F) | Day 1 through Day 4 |
| PK of TD-5202 when given as an SAD: Vz/F | Terminal Phase Volume of Distribution(Vz/F) | Day 1 through Day 4 |
| PK of TD-5202 when given as an SAD: Kel | Elimination Rate (Kel) | Day 1 through Day 4 |
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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 |
|---|---|---|---|---|---|---|
| Theravance Biopharma Investigational Site | Lincoln | Nebraska | 68502 | United States |
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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| Placebo | Drug | Placebo to be administered orally |
|
| PK of TD-5202 when given as an SAD: t 1/2 | Halflife (t 1/2) | Day 1 through Day 4 |
| PK of TD-5202 when given as an MAD: AUC | Area under the plasma concentration-time curve (AUC) | Day 1 and Day 10 |
| PK of TD-5202 when given as an MAD: Cmax | Maximum observed concentration (Cmax) | Day 1 and Day 10 |
| PK of TD-5202 when given as an MAD: Tmax | Time to reach maximum observed concentration (Tmax) | Day 1 and Day 10 |
| PK of TD-5202 when given as an MAD: C trough | concentration at trough (after multiple dosing usually after reaching steady state) (C trough) | Day 2, 4, 6, 8 |
| PK of TD-5202 when given as an MAD: Css | concentration at steady state (Css) | Day 10 |
| PK of TD-5202 when given as an MAD: CL/Fss | Oral clearance at steady state (CL/Fss) | Day 10 |
| PK of TD-5202 when given as an MAD: Cmin | Concentration minimum (after single dosing) (Cmin) | Day 10 |
| PK of TD-5202 when given as an MAD: Vz/Fss | Terminal phase volume of distribution at steady state (Vz/Fss) | Day 10 |
| PK of TD-5202 when given as an MAD: Kel | Elimination Rate (Kel) | Day 10 |
| PK of TD-5202 when given as an MAD: t 1/2 | Halflife (t 1/2) | Day 10 |