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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C Infection

Treatments: Drug: Daclatasvir; Drug: Asunaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02323594

AI447-111

Details and patient eligibility

About

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

Enrollment: 88 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 4 patient groups

Group 1: Daclatasvir

Experimental group

Description:

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

Treatment:

Drug: Daclatasvir

Drug: Daclatasvir

Drug: Daclatasvir

Group 2: Daclatasvir

Experimental group

Description:

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

Treatment:

Drug: Daclatasvir

Drug: Daclatasvir

Drug: Daclatasvir

Group 3: Asunaprevir

Experimental group

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

Treatment:

Drug: Asunaprevir

Group 4: Daclatasvir

Experimental group

Description:

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

Treatment:

Drug: Daclatasvir

Drug: Daclatasvir

Drug: Daclatasvir