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| ID | Type | Description | Link |
|---|---|---|---|
| C4791008 | Other Identifier | Alias Study Number |
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A study to learn about the bioequivalence (the biochemical similarity of two medicines that share the same active ingredient and desired outcome for patients) of the study medicine called APX001 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APX001 Treatment A | Active Comparator | Oral tablet with a 25% drug load (low-load) in fasted participants |
|
| APX001A Treatment B | Experimental | Oral tablet with a high drug load in fasted participants |
|
| APX001A Treatment C | Experimental | Oral tablet with a high drug load in participants that are not fasted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APX001 | Drug | Low-load oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose | |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose | |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose | |
| Area Under the Curve From Time Zero to 24 hours (AUC0-24) | Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose | |
| Percentage of Area Under the Curve Extrapolated to Infinity (%AUCextra) | Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose | |
| Plasma Decay Half-Life (t1/2) | Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose | |
| Apparent Terminal Elimination Rate Constant (λz) | Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose | |
| Apparent Total clearance, Calculated as Dose/AUCinf (CL/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Engelhardt | Basilea Pharmaceutica International Ltd, Allschwil | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceuticals Research Associates, Inc | Salt Lake City | Utah | 84124 | United States |
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| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| C536972 | Torulopsis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C570438 | APX001A |
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| APX001A | Drug | High-load oral tablet |
|
|
| Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose |
| Apparent Volume of Distribution at Terminal Phase (Vz/F) | Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose |
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Baseline through Day 14 |
| Number of Participants With Change From Baseline in Laboratory Tests Results | Baseline through Day 14 |
| Number of Participants With Clinically Significant Change in Vital Signs | Baseline through Day 14 |
| Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Abnormalities | Baseline through Day 14 |
| Number of Participants With Abnormalities in Physical Examinations | Baseline through Day 14 |