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| Name | Class |
|---|---|
| Alexion Pharmaceuticals, Inc. | INDUSTRY |
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This is an open-label, two-group, fixed-sequence study to evaluate the effect of ACH-3102 and Simeprevir on AL-335 pharmacokinetics in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: AL-335, Simeprevir and ACH-3102 | Active Comparator | AL-335, ACH-3102, and Simeprevir dosed in healthy human volunteers once daily for 24 days. |
|
| Group 2: AL-335, Simeprevir and ACH-3102 | Active Comparator | AL-335, ACH-3102, and Simeprevir dosed in healthy human volunteers once daily for 24 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-335 | Drug | AL-335 is a prodrug being developed as an orally administered anti-HCV therapeutic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Multiple dose PK Profile, Cmax and AUC: effect of ACH-3102 on AL-335 and metabolites | To evaluate the effect of multiple oral doses of ACH-3102, on the multiple oral dose PK of AL-335 and metabolites | From screening to Day 28 follow-up visit |
| Multiple dose PK Profile, Cmax and AUC: effect of Simeprevir on AL-335 and metabolites | To evaluate the effect of multiple oral doses of Simeprevir, on the multiple oral dose PK of AL-335 and metabolites | From screening to Day 24 visit |
| Multiple dose PK Profile, Cmax and AUC: effect of ACH-3102 and Simeprevir on AL-335 and metabolites | To evaluate the effect of multiple oral doses of ACH-3102 and Simeprevir, on the multiple oral dose PK of AL-335 and metabolites | From screening to Day 28 follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Data: Composite number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG and abnormal clinical laboratory results | Tabulation of the number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG and abnormal clinical laboratory results (including chemistry, hematology, and urine). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotrial | Rennes | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30350297 | Derived | Valade E, Valenzuela B, Kakuda TN, Westland C, McClure MW, Ouwerkerk-Mahadevan S, Perez-Ruixo JJ, Ackaert O. Characterizing the Pharmacokinetic Interaction Between Simeprevir and Odalasvir in Healthy Volunteers Using a Population Modeling Approach. AAPS J. 2018 Oct 22;20(6):111. doi: 10.1208/s12248-018-0271-0. | |
| 29736243 | Derived |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000629483 | adafosbuvir |
| C000629482 | odalasvir |
| D000069616 | Simeprevir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| ACH-3102 | Drug | ACH-3102 is an NS5A inhibitor being developed as an orally administered anti-HCV therapeutic. |
|
| Simeprevir | Drug | Simeprevir is an orally active, small molecule inhibitor of the NS3/4A protease of HCV and indicated for the treatment of chronic HCV infection as a component of a combination antiviral treatment regimen. |
|
|
| From screening to Day 28 follow-up visit |
| Steady-state PK Profile from Clast, t1/2, Tmax, Tlast, CL/F, Vz/F, λz: effect of AL-335 and ACH-3102 on Simeprevir | To determine the potential effect of AL-335 and/or ACH-3102 on the steady-state PK of Simeprevir. | From screening to Day 28 follow-up visit |
| Steady-state PK Profile from Clast, t1/2, Tmax, Tlast, CL/F, Vz/F, λz: effect of AL-335 and Simeprevir on ACH-3102 | To determine the potential effect of AL-335 and/or Simeprevir on the steady-state PK of ACH-3102. | From screening to Day 28 follow-up visit |
| Kakuda TN, McClure MW, Westland C, Vuong J, Homery MC, Poizat G, Viguerie L, Denot C, Patat A, Zhang Q, Hui J, Apelian D, Smith DB, Chanda SM, Fry J. Pharmacokinetics, safety, and tolerability of the 2- and 3-direct-acting antiviral combination of AL-335, odalasvir, and simeprevir in healthy subjects. Pharmacol Res Perspect. 2018 Apr 30;6(3):e00395. doi: 10.1002/prp2.395. eCollection 2018 Jun. |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006575 |
| Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |