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A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir

Primary Purpose

Hepatitis C Infection

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Daclatasvir

Asunaprevir

Daclatasvir

About this trial

This is an interventional basic science trial for Hepatitis C Infection

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Signed Written Informed Consent must be obtained from the subjects in accordance with requirements of the study center's Institutional review Board (IRB)/ Institutional Ethics Committee (IEC)
Target Population: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
Age and Reproductive Status : Males and females, ages 18 to 49 years, inclusive. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 24 hours prior to the start of study drug and must be using an acceptable method of contraception for 4 weeks prior to study drug administration. Women must not be breastfeeding.

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:

Medical History and Concurrent Diseases : Any significant acute or chronic medical illness. Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug. Any major surgery within 4 weeks of study drug administration. Any gastrointestinal surgery that could impact upon the absorption of study drug (appendectomies with no complications are allowed at the investigator's discretion). Inability to tolerate oral medication, smokers or recent durg or alcohol abuse and Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
Physical and Laboratory Test Findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population, positive urine screen for drugs, positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibodies.
Allergies and Adverse Drug Reaction : History of allergy to DCV, ASV, Hepatitis C virus (HCV) NS3 protease inhibitors, HCV NS5A replication cofactors, or related compounds.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Group 1: Daclatasvir

Group 2: Daclatasvir

Group 3: Asunaprevir

Group 4: Daclatasvir

Arm Description

Single oral dose of Daclatasvir (DCV) tablet and single oral dose of DCV pediatric chewable tablet

Single oral dose of Daclatasvir (DCV) pediatric chewable tablet and single oral dose of DCV pediatric chewable tablet

Single oral dose of Asunaprevir (ASV) tablet, single oral dose of ASV pediatric chewable tablet and single oral dose of ASV pediatric chewable tablets

Single oral dose of Daclatasvir (DCV) tablet and single oral dose of DCV tablets

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration [Cmax]

Area under the concentration-time curve [AUC] from time zero extrapolated to infinite time [AUC(INF)]

AUC from time zero to the time of last quantifiable concentration [AUC(0-T)]

Time of maximum observed plasma concentration [Tmax]

Terminal plasma half life [T-HALF])

Secondary Outcome Measures

Adverse Event reports

Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.

Vital sign measurements

ECGs

Physical examinations

Clinical laboratory tests

The incidence of reported AEs will be tabulated and reviewed for potential significance and clinical importance.

Full Information

NCT ID

NCT02323594

First Posted

December 9, 2014

Last Updated

February 23, 2015

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02323594

Brief Title

A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir

Official Title

A Bioequivalence Study of the 90-mg Daclatasvir Tablet Relative to the 3 × 30-mg Daclatasvir Phase 3 Tablets, and Relative Bioavailability Studies of Chewable Pediatric Tablets of Daclatasvir and Asunaprevir in Healthy Adult Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Infection

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Daclatasvir

Arm Type

Experimental

Arm Description

Single oral dose of Daclatasvir (DCV) tablet and single oral dose of DCV pediatric chewable tablet

Arm Title

Group 2: Daclatasvir

Arm Type

Experimental

Arm Description

Single oral dose of Daclatasvir (DCV) pediatric chewable tablet and single oral dose of DCV pediatric chewable tablet

Arm Title

Group 3: Asunaprevir

Arm Type

Experimental

Arm Description

Single oral dose of Asunaprevir (ASV) tablet, single oral dose of ASV pediatric chewable tablet and single oral dose of ASV pediatric chewable tablets

Arm Title

Group 4: Daclatasvir

Arm Type

Experimental

Arm Description

Single oral dose of Daclatasvir (DCV) tablet and single oral dose of DCV tablets

Intervention Type

Drug

Intervention Name(s)

Daclatasvir

Intervention Description

Treatment A= single oral dose of Daclatasvir (DCV) tablet and Treatment B= single oral dose of DCV pediatric chewable tablet

Intervention Type

Drug

Intervention Name(s)

Daclatasvir

Intervention Description

Treatment C= single oral dose of Daclatasvir (DCV) pediatric chewable tablet and Treatment D= single oral dose of DCV pediatric chewable tablet

Intervention Type

Drug

Intervention Name(s)

Asunaprevir

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Daclatasvir

Intervention Description

Treatment H= single oral dose of Daclatasvir (DCV) tablet and Treatment I= single oral dose of DCV tablets

Primary Outcome Measure Information:

Title

Maximum observed plasma concentration [Cmax]

Time Frame