Skip to main content
OpenTrials
Completed

NCT Number: NCT02108639

To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet

Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Of Miami Inc., Miami, Florida, United States

Loading trial locations.

About this study

IND Number: 79,599/101,943

Primary Purpose: Other - Phase 1 Clinical Pharmacology study to determine the effect of renal impairment on the exposure of DCV, ASV, BMS-791325 (fixed dosed combination) and BMS-791325 given in multiple doses

Fixed dose combination (FDC)

Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325 (DCV 3DAA FDC)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Subjects in Group A must be in good health and have normal renal function
  • Subjects in Groups B-E may have clinical, Electrocardiogram (ECG) and laboratory findings consistent with their degree of renal dysfunction
  • Women of childbearing potential (WOCBP) and male participants must agree to follow the required contraceptive methods

Exclusion criteria

  • Subjects in Group A must not have any significant acute or chronic illnesses
  • Subjects in Groups B-E must not have uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, and/or neurological disease within 6 months of screening
  • Subjects in Groups B-E may not have evidence of rapidly deteriorating renal function, defined as a screening creatinine clearance (CLcr) which has decreased from a previous CLcr by 50% within the last 3 months
  • Prior exposure to DCV, ASV or BMS-791325 within 3 months prior to study drug administration

Treatment and study plan

DCV 3DAA FDC

Drug

Other names: Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325

BMS-791325

Drug

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) for DCV, ASV, BMS-791325 and BMS-794712

    Time frame: For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12

  2. Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) for DCV, ASV, BMS-791325 and BMS-794712

    Time frame: For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12

Secondary outcomes

  1. Concentration at 12 hours (C12) for (DCV, ASV, BMS-791325) and BMS-948158

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  2. Time of maximum observed concentration (Tmax) for (DCV, ASV, BMS-791325) and BMS-948158

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  3. Apparent total body clearance (CLT/F) for (DCV, ASV and BMS-791325 only)

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  4. Trough observed plasma concentration (Ctrough) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  5. Cmax fraction unbound (Cmaxfu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

    BMS-948158 may also be analyzed

  6. AUC(TAU) fraction unbound (AUC(TAU) fu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

    BMS-948158 may also be analyzed

  7. Protein Binding for DCV, ASV, BMS-791325 and BMS-794712

    Time frame: 1 and 4 hours postdose on Day 10 (all subjects) and Day 12 (Group E only)

  8. Total amount recovered in urine (URt) for (DCV, ASV, BMS-791325) and BMS-794712

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  9. Total percent of administered dose recovered in urine (%URt) for (DCV, ASV, and BMS-791325 only)

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  10. Renal clearance (CLR) for DCV, ASV, BMS-791325, and BMS-794712

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  11. Maximum observed concentration (Cmax) for BMS-948158

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  12. Area under the concentration-time curve in 1 dosing interval (AUC (TAU)) for BMS-948158

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  13. Safety based on occurrence of Adverse Event (AEs), Serious adverse event (SAEs) and AEs leading to discontinuation

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  14. Safety based on abnormalities in vital sign measurements

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  15. Safety based on findings on ECG measurements and physical examinations

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

  16. Safety based on Marked abnormalities in clinical laboratory test findings

    Time frame: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Fixed Dose Combination Formulation of DCV, ASV, and BMS-791325 in Subjects With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-stage Renal Dysfunction

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.