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This is a 4-part study. Part A will be a randomized, double-blind, placebo-controlled investigation of single ascending doses (SAD) to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) biomarkers of TVB-3567 administered orally in healthy participants. Part B will be a randomized, open-label, 2-way crossover investigation to assess the effect of food on a single dose TVB-3567 administered orally in healthy participants. Parts C and D will be randomized, double-blind, placebo-controlled investigations of multiple ascending doses (MAD) to assess the safety, tolerability, PK, and PD/biomarkers of TVB-3567 administered orally in healthy participants without and with moderate to severe acne, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A (SAD in Healthy Participants) | Experimental |
| |
| Part B (Food Effect) | Experimental |
| |
| Part C (MAD in Healthy Participants) | Experimental |
| |
| Part D (MAD in Acne Participants) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TVB-3567 | Drug | Orally administered capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs) | Baseline to 7 to 8 days after dosing | |
| Part B - Plasma AUC0-t in fasted and fed conditions | Area under the concentration-time curve from time zero until the last observed concentration | Baseline to Day 4 |
| Part B - Plasma AUC0-inf in fasted and fed conditions | Area under the concentration-time curve from time zero to infinity | Baseline to Day 4 |
| Part B - Plasma Cmax in fasted and fed conditions | Maximum concentration measurement in plasma | Baseline to Day 4 |
| Part B - Incidence of adverse events (AEs) and serious adverse events (SAEs) under fasted and fed conditions | Baseline to 7 to 8 days after dosing | |
| Part C - Incidence of adverse events (AEs) and serious adverse events (SAEs) | Baseline to 13 to 15 days after the last dose | |
| Part D - Incidence of adverse events (AEs) and serious adverse events (SAEs) | Baseline to 13 to 15 days after the last dose |
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Inclusion Criteria:
Healthy Participants (Parts A, B and C)
Healthy Participants with Acne (Part D only)
Participants must meet all of the above criteria, as well as the following inclusion criteria to be eligible for participation in the study:
Exclusion Criteria:
Healthy Participants (Parts A, B and C)
History or presence of clinically significant medical or psychiatric condition or disease
History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds including over the counter acne products.
Has a clinically significant ophthalmic examination finding
Female participant of childbearing potential
Unable to refrain from or anticipates the use of:
Healthy Participants with Acne (Part D only)
Participants must not be enrolled if they do not meet any of the above criteria, as well as the following exclusion criteria:
Unable to refrain from or anticipates the use of:
Significant skin diseases
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | (650) 561-8600 | SB3567-CLIN-001@sagimet.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. | Completed | Tempe | Arizona | 85283 | United States | |
| Nucleus Network |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Placebo | Drug | Orally administered capsule |
|
| Recruiting |
| Melbourne |
| Victoria |
| 3004 |
| Australia |