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The goal of this study is to assess the bioequivalence (BE) between the liquid formulation and the new solid formulation of ABX-002 under fasting conditions and to evaluate the effect of food on the pharmacokinetics (PK) of the new solid formulation of ABX-002.This study design is consistent with FDA guidelines for the assessment of BE.
This was an open label, randomized, single dose, three-way crossover BE and food-effect study. Therefore, the total number of participants in this study was 18.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence ABC | Experimental | Sequence ABC |
|
| Sequence BCA | Experimental | Sequence BCA |
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| Sequence CAB | Experimental | Sequence CAB |
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| Sequence ACB | Experimental | Sequence ACB |
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| Sequence BAC | Experimental | Sequence BAC |
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| Sequence CBA | Experimental | Sequence CBA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABX-002 | Drug | ABX-002 was supplied as a solution and solid dose form. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation in healthy adult participants. | Change in Area Under the Curve from time zero to the last quantifiable concentration for ABX-002 and LL-340001 | 8 weeks |
| Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation | Change in Area Under the Curve from time zero to infinity for ABX-002 and LL-340001 | 8 weeks |
| Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation | Change in Peak Plasma Concentration for ABX-002 and LL-340001 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants | Change in Change in Area Under the Curve from time zero to the last quantifiable concentration for ABX-002 and LL-340001 | 8 weeks |
| Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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Participants received each treatment on one occasion. The treatment sequences participants were randomized to included: ABC, BCA, CAB, ACB, BAC, and CBA.
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Change in Area Under the Curve from time zero to infinity for ABX-002 and LL-340001 |
| 8 weeks |
| Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants | Change in Peak Plasma Concentration for ABX-002 and LL-340001 | 8 weeks |
| Evaluate the safety and tolerability of 3 total doses of ABX-002 in healthy adult participants. | Incidence and severity of treatment-emergent adverse events to ABX-002 will be measured | 8 weeks |