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The primary purpose of this study is to evaluate the effect of carbamazepine, a strong CYP3A4 inducer, on the steady-state pharmacokinetics (PK) of tavapadon in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tavapadon Followed by Tavapadon + Carbamazepine | Experimental | Participants will receive oral tavapadon tablets titrated up to a steady-state dose from Day 1 to Day 14. From Day 15, participants will receive oral carbamazepine tablets titrated up to a steady-state dose along with oral tavapadon tablets, up to Day 30. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tavapadon | Drug | Oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Tavapadon | Pre-dose and at multiple timepoints post-dose up to Day 31 | |
| Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCÏ„) of Tavapadon | Pre-dose and at multiple timepoints post-dose up to Day 31 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and AEs by Severity | Day 1 up to Day 36 | |
| Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values | Up to Day 31 |
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Inclusion Criteria:
Exclusion Criteria:
"Yes" responses for any of the following items on the C-SSRS (within past 6 months):
Serious risk of suicide in the opinion of the investigator is also exclusionary.
Participants shown to carry or be positive for human leukocyte antigen (HLA)-B*1502 or HLA-A*3101.
Use of prohibited medication prior to randomization (5 half-lives) or likely to require prohibited concomitant therapy (e.g., prescription and over-the-counter medications, herbal medications, vitamins, and supplements) during the trial. CYP3A4 inhibitors and inducers are prohibited from 30 days prior to signing of the ICF through the end of the trial.
Recent monoamine oxidase inhibitors (MAO-I) use (in the last 28 days) as it increases the risk for hypersensitivity and bone marrow suppression from carbamazepine.
Prior carbamazepine use that was discontinued for tolerability or adverse events, including a clinically significant decrease in platelets, white blood cells or hemoglobin.
Platelets, white blood cell count, or hemoglobin \
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madison, Wisconsin | Madison | Wisconsin | 53704 | United States |
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| Carbamazepine | Drug | Extended-release oral tablets |
|
| Number of Participants with Clinically Significant Changes in Vital Sign Values | Up to Day 31 |
| Number of Participants with Clinically Significant Changes in Clinical Laboratory Assessments | Up to Day 30 |
| Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results | Up to Day 31 |
| Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk. | Up to Day 31 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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