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

NCT02323594 | Completed Phase 1

• 1 other identifier: AI447-111
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (6)

• Adverse Event reports

  30 days after last dose

• Vital sign measurements

  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

Study Arms (4)

Group 1: Daclatasvir

EXPERIMENTAL

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

Drug: Daclatasvir

Group 2: Daclatasvir

EXPERIMENTAL

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

Drug: Daclatasvir

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

Drug: Asunaprevir

Group 4: Daclatasvir

EXPERIMENTAL

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

Drug: Daclatasvir

Interventions

Daclatasvir DRUG

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

Group 1: Daclatasvir

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

Group 3: Asunaprevir

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

daclatasvir; asunaprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Rebecca N Wood-Horrall, MD

  PPD Development, LP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 23, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 24, 2015

Record last verified: 2014-12