NCT01830205

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

November 16, 2015

Completed
Last Updated

November 16, 2015

Status Verified

November 1, 2015

Enrollment Period

9 months

First QC Date

April 10, 2013

Results QC Date

August 19, 2015

Last Update Submit

November 13, 2015

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir

    AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant. The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment. Mild participants were counted as per their original allocation.

    Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

Secondary Outcomes (15)

  • Unbound Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity Time (AUC(INF)u) of Daclatasvir

    Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

  • Maximum Observed Plasma Concentration (Cmax) of Daclatasvir

    Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

  • Unbound Maximum Observed Plasma Concentrations of Daclatasvir

    Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

  • Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration [AUC(0-T)] of Daclatasvir

    Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Daclatasvir

    Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose

  • +10 more secondary outcomes

Study Arms (4)

Group A (Normal renal function): Daclatasvir

EXPERIMENTAL

Daclatasvir 60 mg tablet by mouth single dose on Day 1

Drug: Daclatasvir

Group B (End Stage Renal Disease): Daclatasvir

EXPERIMENTAL

Daclatasvir 60 mg tablet by mouth single dose on Day 1

Drug: Daclatasvir

Group C (Moderate renal impairment): Daclatasvir

EXPERIMENTAL

Daclatasvir 60 mg tablet by mouth single dose on Day 1

Drug: Daclatasvir

Group D (Severe renal impairment): Daclatasvir

EXPERIMENTAL

Daclatasvir 60 mg tablet by mouth single dose on Day 1

Drug: Daclatasvir

Interventions

DaclatasvirDRUG
Also known as: BMS-790052
Group A (Normal renal function): DaclatasvirGroup B (End Stage Renal Disease): DaclatasvirGroup C (Moderate renal impairment): DaclatasvirGroup D (Severe renal impairment): Daclatasvir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Meet renal function criteria in one of four categories

You may not qualify if:

  • \- Unstable or uncontrolled medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Davita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (1)

  • 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.

    PMID: 25654812DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

daclatasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 12, 2013

Study Start

September 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 16, 2015

Results First Posted

November 16, 2015

Record last verified: 2015-11

Locations

US(2)