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The primary purpose of this study is to evaluate the effect of steady-state NAL ER on the pharmacokinetics (PK) of pirfenidone or nintedanib and the effect of steady-state pirfenidone or nintedanib on the PK of NAL ER in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1 - NAL ER + Pirfenidone | Experimental | Participants will receive NAL ER followed by NAL ER co-administered with pirfenidone. |
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| Cohort A2 - NAL ER + Nintedanib | Experimental | Participants will receive NAL ER followed by NAL ER co-administered with nintedanib. |
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| Cohort B1 - Pirfenidone + NAL ER | Experimental | Participants will receive pirfenidone followed by pirfenidone co-administered with NAL ER. |
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| Cohort B2 - Nintedanib + NAL ER | Experimental | Participants will receive nintedanib followed by nintedanib co-administered with NAL ER. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAL ER | Drug | Oral tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and Nintedanib | Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2 | |
| Time to Reach Maximum Observed Concentration (Tmax) of NAL ER, Pirfenidone, and Nintedanib | Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2 | |
| Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER, Pirfenidone, and Nintedanib | Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2 | |
| Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER, Pirfenidone, and Nintedanib | Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2 | |
| Apparent Terminal Rate Constant (λz) of NAL ER, Pirfenidone, and Nintedanib | Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2 | |
| Apparent Terminal Half-Life (t1/2) of NAL ER, Pirfenidone, and Nintedanib | Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2 | |
| Apparent Clearance (CL/F) of NAL ER, Pirfenidone, and Nintedanib | Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to Day 21 | |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Up to Day 21 |
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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 | Miami | Florida | 33172 | United States |
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| Pirfenidone | Drug | Oral tablets |
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| Nintedanib | Drug | Oral capsules |
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| Apparent Volume of Distribution (Vz/F) of NAL ER, Pirfenidone, and Nintedanib | Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2 |
| ID | Term |
|---|---|
| C093844 | pirfenidone |
| C530716 | nintedanib |
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