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Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment

NCT ID: NCT01830205

Last Updated: 2015-11-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to assess the effect of renal function impairment on the single dose pharmacokinetics of Daclatasvir.

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Detailed Description

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Treatment, Parallel Assignment, Open Label, Non-Randomized, Single Dose Adaptive Design, Pharmacokinetics Study

Conditions

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Hepatitis C

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A (Normal renal function): Daclatasvir

Daclatasvir 60 mg tablet by mouth single dose on Day 1

Group Type EXPERIMENTAL

Daclatasvir

Intervention Type DRUG

Group B (End Stage Renal Disease): Daclatasvir

Daclatasvir 60 mg tablet by mouth single dose on Day 1

Group Type EXPERIMENTAL

Daclatasvir

Intervention Type DRUG

Group C (Moderate renal impairment): Daclatasvir

Daclatasvir 60 mg tablet by mouth single dose on Day 1

Group Type EXPERIMENTAL

Daclatasvir

Intervention Type DRUG

Group D (Severe renal impairment): Daclatasvir

Daclatasvir 60 mg tablet by mouth single dose on Day 1

Group Type EXPERIMENTAL

Daclatasvir

Intervention Type DRUG

Interventions

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Daclatasvir

Intervention Type DRUG

Other Intervention Names

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BMS-790052

Eligibility Criteria

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Inclusion Criteria

\- Meet renal function criteria in one of four categories

Exclusion Criteria

\- Unstable or uncontrolled medical conditions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

Davita Clinical Research

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Garimella T, Wang R, Luo WL, Hwang C, Sherman D, Kandoussi H, Marbury TC, Alcorn H, Bertz R, Bifano M. Single-dose pharmacokinetics and safety of daclatasvir in subjects with renal function impairment. Antivir Ther. 2015;20(5):535-43. doi: 10.3851/IMP2941. Epub 2015 Feb 5.

Reference Type DERIVED
PMID: 25654812 (View on PubMed)

Related Links

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http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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AI444-063

Identifier Type: -

Identifier Source: org_study_id

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