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Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)

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ClinicalTrials.gov Identifier: NCT01813513
Recruitment Status : Completed
First Posted : March 19, 2013
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus low-fat meals on the PK of IDX719.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: IDX719 Drug: Simeprevir Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 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 and Simeprevir in Healthy Subjects
Study Start Date : January 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Simeprevir

Arm Intervention/treatment
Experimental: Group A: IDX719 then IDX719/Simeprevir
Healthy participants take IDX719 150 mg once daily (QD) on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.
Drug: IDX719
50 mg tablet for oral administration
Other Name: Samatasvir

Drug: Simeprevir
150 mg capsule for oral administration
Other Name: Olysio™

Experimental: Group B: Simeprevir then IDX719/Simeprevir
Healthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.
Drug: IDX719
50 mg tablet for oral administration
Other Name: Samatasvir

Drug: Simeprevir
150 mg capsule for oral administration
Other Name: Olysio™

Experimental: Group C: IDX719
Healthy participants take IDX719 150 mg QD on Days 1-14.
Drug: IDX719
50 mg tablet for oral administration
Other Name: Samatasvir

Experimental: Group D: IDX719/Simeprevir
Participants from Groups A and B will be asked to return for Group D. Participants take IDX719 and simeprevir QD on Days 1-7 to determine the impact of food on single-dose (on Day 1) and steady state (Day 7) PK.
Drug: IDX719
50 mg tablet for oral administration
Other Name: Samatasvir

Drug: Simeprevir
150 mg capsule for oral administration
Other Name: Olysio™

Experimental: Group E: High-Fat then Low-Fat PK
Participants from Group C will return to determine the PK of IDX719 after high-fat (Day 1) and low-fat (Day 7) meals (Days 2-6 are drug-free washout).
Drug: IDX719
50 mg tablet for oral administration
Other Name: Samatasvir

Experimental: Group F: Low-Fat then High-Fat PK
Participants from Group C will return to determine the PK of IDX719 after low-fat (Day 1) and high-fat (Day 7) meals (Days 2-6 are drug-free washout).
Drug: IDX719
50 mg tablet for oral administration
Other Name: Samatasvir




Primary Outcome Measures :
  1. Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss) [ Time Frame: Up to 30 days ]
  2. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 30 days ]
  3. AUC from time zero to infinity [ Time Frame: Up to 30 days ]
  4. Trough plasma concentration (Ctrough) [ Time Frame: Up to 30 days ]

Secondary Outcome Measures :
  1. Percentage of participants experiencing serious adverse events (SAEs) [ Time Frame: Up to 30 days ]
  2. Percentage of participants experiencing adverse events (AEs) [ Time Frame: Up to 30 days ]
  3. Percentage of participants experiencing Grade 1-4 laboratory abnormalities [ Time Frame: Up to 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Has no clinically significant abnormalities on medical history, physical examination, or 12-lead electrocardiogram (ECG)
  • 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 study drug
  • Agrees to avoid nicotine-containing products from 3 months prior to Screening and for the duration of the study

Exclusion Criteria:

  • Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) antibodies
  • Is pregnant or breastfeeding
  • Has previously received either IDX719 or simeprevir
  • Has participated in another clinical drug study within 30 days of Screening

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): NCT01813513


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01813513    
Other Study ID Numbers: 1894-004
IDX-06A-004 ( Other Identifier: Idenix Protocol Number )
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016
Keywords provided by Merck Sharp & Dohme Corp.:
HCV
Hepatitis C Virus
Hepatitis C
antiviral drugs
liver
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Simeprevir
Antiviral Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action