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Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)

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ClinicalTrials.gov Identifier: NCT01907724
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : January 26, 2016
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also be assessed.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: IDX719 Drug: Simeprevir Drug: TMC647055 Drug: RTV Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Subjects
Study Start Date : May 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IDX719 + RTV
Participants take IDX719 150 mg once daily (QD) + ritonavir 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
Drug: IDX719
IDX719 will be supplied as a 50 mg tablet for oral administration.

Drug: Simeprevir
Simeprevir will be supplied as 75 mg capsules for oral administration.
Other Name: Olysio™

Drug: TMC647055
TMC647055 will be supplied as 150 mg capsules for oral administration.

Drug: RTV
RTV will be supplied as 80 mg/mL solution for oral administration.
Other Name: Norvir™

Experimental: Simeprevir/TMC647055 + RTV
Participants take simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
Drug: IDX719
IDX719 will be supplied as a 50 mg tablet for oral administration.

Drug: Simeprevir
Simeprevir will be supplied as 75 mg capsules for oral administration.
Other Name: Olysio™

Drug: TMC647055
TMC647055 will be supplied as 150 mg capsules for oral administration.

Drug: RTV
RTV will be supplied as 80 mg/mL solution for oral administration.
Other Name: Norvir™




Primary Outcome Measures :
  1. Observed maximum plasma drug concentration (Cmax) [ Time Frame: Up to 14 days ]
  2. Time to maximum concentration (Tmax) [ Time Frame: Up to 14 days ]
  3. Area under the drug concentration-plasma time curve from time zero to last measurable concentration (AUC0-t) [ Time Frame: Up to 14 days ]
  4. Predose trough concentration (Ctrough) [ Time Frame: Up to 14 days ]
  5. Apparent terminal elimination rate constant [ Time Frame: Up to 14 days ]
  6. Observed terminal half-life (T1/2) [ Time Frame: Up to 14 days ]

Secondary Outcome Measures :
  1. Percentage of participants experiencing serious adverse events (SAEs) [ Time Frame: Up to 28 days ]
  2. Percentage of participants experiencing adverse events (AEs) [ Time Frame: Up to 28 days ]
  3. Percentage of participants with Grade 1-4 laboratory abnormalities [ Time Frame: Up to 28 days ]


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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Agrees to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug
  • Male participants agree not to donate sperm from Day -1 through 90 days after the last dose of study drug

Exclusion Criteria:

  • Is pregnant or breastfeeding
  • Has another clinically significant medical conditions or laboratory abnormality(s)

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): NCT01907724


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Janssen Research & Development, LLC
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01907724     History of Changes
Other Study ID Numbers: 1894-007
IDX-06A-007 ( Other Identifier: Idenix Protocol Number )
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016

Keywords provided by Merck Sharp & Dohme Corp.:
Chronic hepatitis C
Hepatitis C virus
HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Ritonavir
Simeprevir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors