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This study will assess the relative bioavailability of two different Oral formulations of tavapadon in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tavapadon: Part 1-Sequence 1 | Experimental | Participants will receive Clinical Tavapadon Dose A in Period 1, followed by Commercial Tavapadon Dose B in Period 2 |
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| Tavapadon: Part 1-Sequence 2 | Experimental | Participants will receive Commercial Clinical Tavapadon Dose B in Period 1, followed by Clinical Tavapadon Dose A in Period 2 |
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| Tavapadon: Part 2-Sequence 1 | Experimental | Participants will receive Clinical Tavapadon Dose C in Period 1, Clinical Tavapadon Dose D in Period 2 followed by Commercial Tavapadon Dose E in Period 3 |
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| Tavapadon: Part 2-Sequence 2 | Experimental | Participants will receive Clinical Tavapadon Dose C in Period 1, Commercial Tavapadon Dose E in Period 2 followed by Clinical Tavapadon Dose D in Period 3 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tavapadon | Drug | Oral: Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment | Up to approximately 53 days |
| Maximum Observed Plasma Concentration (Cmax) of Tavapadon | (Cmax) of Tavapadon | Up to approximately 22 days |
| Time to Cmax (Tmax) of Tavapadon | Tmax of Tavapadon | Up to approximately 22 days |
| Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon | Apparent Terminal Phase Elimination Rate Constant (β) of Tavapadon | Up to approximately 22 days |
| Terminal Phase Elimination Half-life (t1/2) of Tavapadon | Terminal Phase Elimination Half-life (t1/2) of Tavapadon | Up to approximately 22 days |
| Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCÏ„) of Tavapadon | Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCÏ„) of Tavapadon | Up to approximately 22 days |
| Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon | Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon |
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Inclusion Criteria:
Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at the time of screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG
Females, Non-Childbearing Potential due to meeting the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 275870 | Grayslake | Illinois | 60030 | United States |
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| Up to approximately 22 days |
| Trough Concentration (Ctrough) of Tavapadon | Trough Concentration (Ctrough) of Tavapadon | Up to approximately 22 days |