NCT01886599

Brief Summary

The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

3 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

November 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
Last Updated

November 11, 2013

Status Verified

November 1, 2013

Enrollment Period

3 months

First QC Date

June 24, 2013

Last Update Submit

November 8, 2013

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • AUC(TAU) of Asunaprevir assessed using plasma concentrations on Day 7

    Area under the concentration-time curve in one dosing interval \[AUC(TAU)\] will be calculated from the blood drug concentration versus time curve

    11 time points on Day 7

Secondary Outcomes (16)

  • Plasma protein binding (PB) of Asunaprevir will be determined from the 1 hour and 3 hour time points post-dose

    1 and 3 hours of Day 7

  • Maximum observed plasma concentration (Cmax) of Asunaprevir

    30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)

  • Unbound Maximum observed plasma concentrations (Cmaxu) of Asunaprevir

    30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)

  • Time of maximum observed plasma concentration (Tmax) of Asunaprevir

    30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)

  • Minimum observed plasma concentration at one dose interval (C12) of Asunaprevir

    30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)

  • +11 more secondary outcomes

Study Arms (5)

Arm A: Subjects with normal renal function

EXPERIMENTAL

Asunaprevir 100 mg tablet by mouth twice daily for 7 days

Drug: Asunaprevir

Arm B: Subjects with end stage renal disease

EXPERIMENTAL

Asunaprevir 100 mg tablet by mouth twice daily for 7 days

Drug: Asunaprevir

Arm C: Subjects with mild renal impairment

EXPERIMENTAL

Asunaprevir 100 mg tablet by mouth twice daily for 7 days

Drug: Asunaprevir

Arm D: Subjects with moderate renal impairment

EXPERIMENTAL

Asunaprevir 100 mg tablet by mouth twice daily for 7 days

Drug: Asunaprevir

Arm E: Subjects with severe renal impairment

EXPERIMENTAL

Asunaprevir 100 mg tablet by mouth twice daily for 7 days

Drug: Asunaprevir

Interventions

AsunaprevirDRUG
Also known as: BMS-650032
Arm A: Subjects with normal renal functionArm B: Subjects with end stage renal diseaseArm C: Subjects with mild renal impairmentArm D: Subjects with moderate renal impairmentArm E: Subjects with severe renal impairment

Eligibility Criteria

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

You may qualify if:

  • Group A: Subjects with normal renal function
  • Group B: Patients with end stage renal disease
  • Group C: Patients with mild renal impairment
  • Group D: Patients with moderate renal impairment
  • Group E: Patients with severe renal impairment

You may not qualify if:

  • History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric and/or neurological disease
  • Hepatitis B or C
  • Human Immunodeficiency Virus (HIV)
  • Recent gastrointestinal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Davita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

New Orleans Center For Clinical Research

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

asunaprevir

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 24, 2013

First Posted

June 26, 2013

Study Start

November 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

November 11, 2013

Record last verified: 2013-11

Locations

US(3)