Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104843
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Daclatasvir, Asunaprevir and BMS-791325 FDC Drug: BMS-791325 Drug: Rosuvastatin Phase 1

Detailed Description:

IND Number: 79,599/101,943

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effect of Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Therapy on the Pharmacokinetics of Rosuvastatin
Study Start Date : April 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin

Treatment A: Rosuvastatin tablet orally on specified days

Treatment B: Daclatasvir, Asunaprevir and BMS-791325 Fixed dose combination (FDC) + BMS-791325 tablet orally on specified days

Treatment C: Daclatasvir, Asunaprevir and BMS-791325 FDC + BMS-791325 + Rosuvastatin tablet orally on specified days

Drug: Daclatasvir, Asunaprevir and BMS-791325 FDC
Drug: BMS-791325
Drug: Rosuvastatin
Other Name: Crestor®




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104843


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol Myers Squibb Bristol-Myers Squibb

Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02104843     History of Changes
Other Study ID Numbers: AI443-115
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Rosuvastatin Calcium
Asunaprevir
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Protease Inhibitors