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

NCT ID: NCT02323594

Last Updated: 2015-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-02-28

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

Conditions

Hepatitis C Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group 1: Daclatasvir

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

Group Type: EXPERIMENTAL

Daclatasvir

Intervention Type: DRUG

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

Group 2: Daclatasvir

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

Group Type: EXPERIMENTAL

Daclatasvir

Intervention Type: DRUG

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

Group 3: Asunaprevir

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 Type: EXPERIMENTAL

Asunaprevir

Intervention Type: 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

Group 4: Daclatasvir

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

Group Type: EXPERIMENTAL

Daclatasvir

Intervention Type: DRUG

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

Interventions

Daclatasvir

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

Intervention Type: DRUG

Daclatasvir

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

Asunaprevir

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

Daclatasvir

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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)

2. Target Population: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.

3. 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

1. 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.

2. 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.

3. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca N Wood-Horrall, MD

Role: PRINCIPAL_INVESTIGATOR

PPD Development, LP

Other Identifiers

AI447-111

Identifier Type: -

Identifier Source: org_study_id