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Grps 1, 2, 3 "This study will be testing the performance of ASV and DCV pediatric chewable tablets.
Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg tablet
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Daclatasvir | Experimental | Single oral dose of Daclatasvir (DCV) tablet and single oral dose of DCV pediatric chewable tablet |
|
| Group 2: Daclatasvir | Experimental | Single oral dose of Daclatasvir (DCV) pediatric chewable tablet and single oral dose of DCV pediatric chewable tablet |
|
| Group 3: Asunaprevir | Experimental | Single oral dose of Asunaprevir (ASV) tablet, single oral dose of ASV pediatric chewable tablet and single oral dose of ASV pediatric chewable tablets |
|
| Group 4: Daclatasvir | Experimental | Single oral dose of Daclatasvir (DCV) tablet and single oral dose of DCV tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug | Treatment A= single oral dose of Daclatasvir (DCV) tablet and Treatment B= single oral dose of DCV pediatric chewable tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration [Cmax] | Before dosing through 96 hours | |
| Area under the concentration-time curve [AUC] from time zero extrapolated to infinite time [AUC(INF)] | Before dosing through 96 hours | |
| AUC from time zero to the time of last quantifiable concentration [AUC(0-T)] | Before dosing through 96 hours | |
| Time of maximum observed plasma concentration [Tmax] | Before dosing through 96 hours | |
| Terminal plasma half life [T-HALF]) | Before dosing through 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event reports | Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. | 30 days after last dose |
| Vital sign measurements |
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Inclusion Criteria:
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for duration of treatment with study drug females must still undergo pregnancy testing as described in this section.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca N Wood-Horrall, MD | PPD Development, LP | Principal Investigator |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C549273 | daclatasvir |
| C571889 | asunaprevir |
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| Daclatasvir | Drug | Treatment C= single oral dose of Daclatasvir (DCV) pediatric chewable tablet and Treatment D= single oral dose of DCV pediatric chewable tablet |
|
| Asunaprevir | Drug | Treatment E= single oral dose of Asunaprevir (ASV) tablet and Treatment F= single oral dose of ASV pediatric chewable tablet and Treatment G= single oral dose of of ASV pediatric chewable tablet |
|
| Daclatasvir | Drug | Treatment H= single oral dose of Daclatasvir (DCV) tablet and Treatment I= single oral dose of DCV tablets |
|
| 30 days after last dose |
| ECGs | 30 days after last dose |
| Physical examinations | 30 days after last dose |
| Clinical laboratory tests | 30 days after last dose |
| The incidence of reported AEs will be tabulated and reviewed for potential significance and clinical importance. | 30 days after last dose |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |