Clinical trial NCT02323594: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-12-23
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


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.

Primary outcomes:
measure: Maximum observed plasma concentration [Cmax]
timeFrame: Before dosing through 96 hours
measure: Area under the concentration-time curve [AUC] from time zero extrapolated to infinite time [AUC(INF)]
timeFrame: Before dosing through 96 hours
measure: AUC from time zero to the time of last quantifiable concentration [AUC(0-T)]
timeFrame: Before dosing through 96 hours
measure: Time of maximum observed plasma concentration [Tmax]
timeFrame: Before dosing through 96 hours
measure: Terminal plasma half life [T-HALF])
timeFrame: Before dosing through 96 hours
Secondary outcomes:
measure: Adverse Event reports
timeFrame: 30 days after last dose
measure: Vital sign measurements
timeFrame: 30 days after last dose
measure: ECGs
timeFrame: 30 days after last dose
measure: Physical examinations
timeFrame: 30 days after last dose
measure: Clinical laboratory tests
timeFrame: 30 days after last dose
measure: The incidence of reported AEs will be tabulated and reviewed for potential significance and clinical importance.
timeFrame: 30 days after last dose
Other outcomes:
Locations:
Study officials:
affiliation: PPD Development, LP
name: Rebecca N Wood-Horrall, MD
role: PRINCIPAL_INVESTIGATOR
References: