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The primary purpose of this study is to evaluate the effect of a high-fat, high-calorie meal on the relative bioavailability of NAL ER following single oral doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: NAL ER Dose A | Experimental | Participants will receive NAL ER Dose A on Day 1 in the fasted state, followed by dosing on Day 5 in the fed state in the first sequence, and vice versa in the second sequence, with a 3-day washout maintained between sequences. |
|
| Cohort 2: NAL ER Dose B | Experimental | Participants will receive NAL ER Dose B on Day 1 in the fasted state, followed by dosing on Day 5 in the fed state in the first sequence, and vice versa in the second sequence, with a 3-day washout maintained between sequences. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAL ER | Drug | Oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Bioavailability of NAL ER | Predose and at multiple timepoints postdose (from Day 1 to Day 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of NAL ER | Predose and at multiple timepoints postdose (from Day 1 to Day 8) | |
| Time to Reach Maximum Observed Concentration (Tmax) of NAL ER | Predose and at multiple timepoints postdose (from Day 1 to Day 8) |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Chief Development Officer | Trevi Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, LLC. | Recruiting | Miami | Florida | 33172 | United States |
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| ID | Term |
|---|---|
| D009266 | Nalbuphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER | Predose and at multiple timepoints postdose (from Day 1 to Day 8) |
| Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER | Predose and at multiple timepoints postdose (from Day 1 to Day 8) |
| Apparent Terminal Rate Constant (λz) of NAL ER | Predose and at multiple timepoints postdose (from Day 1 to Day 8) |
| Apparent Terminal Half-Life (t1/2) of NAL ER | Predose and at multiple timepoints postdose (from Day 1 to Day 8) |
| Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to Day 18 |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |