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Completed

NCT Number: NCT02104843

Drug Interaction Between Daclatasvir/Asunaprevir/BMS-791325 and Rosuvastatin

The primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 combination therapy on the exposure of Rosuvastatin.

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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–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

IND Number: 79,599/101,943

Primary Purpose: Other - Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

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

  • Healthy subjects with no clinically significant deviations from normal in medical history, physical exam findings, 12 lead ECG measurements and clinical laboratory tests
  • Females must be of non-childbearing potential

Exclusion criteria

  • Women of childbearing potential
  • Any significant acute or chronic medical condition
  • Inability to tolerate oral medications
  • Inability to be venipunctured and/or tolerate venous access
  • Abnormal liver function tests
  • Current or recent (within 3 months of dosing) gastrointestinal disease

Treatment and study plan

Daclatasvir, Asunaprevir and BMS-791325 FDC

Drug

BMS-791325

Drug

Rosuvastatin

Drug

Other names: Crestor®

Primary outcomes

  1. Maximum observed concentration (Cmax) of Rosuvastatin

    Time frame: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)

  2. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of Rosuvastatin

    Time frame: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)

  3. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin

    Time frame: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)

Secondary outcomes

  1. Time of maximum observed concentration (Tmax) of Rosuvastatin

    Time frame: Days 1 and 15 (predose through 96 hours)

  2. Half life (T-HALF) of Rosuvastatin

    Time frame: Days 1 and 15 (predose through 96 hours)

  3. Apparent total body clearance (CLT/F) of Rosuvastatin

    Time frame: Days 1 and 15 (predose through 96 hours)

  4. Maximum observed concentration (Cmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712

    Time frame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose

  5. Trough observed plasma concentration (predose) (Ctrough) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712

    Time frame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose

  6. Area under the concentration-time curve in one dosing interval [AUC(TAU)] of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712

    Time frame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose

  7. Time of maximum observed concentration (Tmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712

    Time frame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose

  8. Observed plasma concentration at 12 hours after dosing in a pharmacokinetic (PK) profile (C12) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712

    Time frame: Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose

  9. Safety measured by incidence of Adverse events (AEs), Serious adverse events (SAEs) and AEs leading to discontinuation

    Time frame: Days 1 through 19

  10. Safety measured by results of vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests

    Time frame: Days 1 through 19

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Effect of Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Therapy on the Pharmacokinetics of Rosuvastatin

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2014
Registry last updated
Jul 18, 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.

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