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To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)

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: NCT01813552
Recruitment Status : Completed
First Posted : March 19, 2013
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study is designed to evaluate the potential for an effect of Ritonavir (Norvir®) or omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety and tolerability of the study drugs when administered alone and in combination in healthy participants.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: Samatasvir Drug: Omeprazole Drug: Ritonavir Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Open-label Study to Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of IDX719 in Healthy Subjects
Study Start Date : February 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

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Arm Intervention/treatment
Experimental: Samatasvir + Ritonavir
Days 1, 9 and 13: Healthy Volunteers will take samatasvir in the mornings under fed or fasted conditions with water. Days 5-16: Healthy Volunteers will take ritonavir in the mornings under fasted or fed conditions with water.
Drug: Samatasvir
Samatasvir 150 mg oral tablets (50mg x 3), single dose

Drug: Ritonavir
100 mg oral tablets, once daily

Experimental: Samatasvir + Omeprazole
Days 1, 9 and 13: Healthy Volunteers will take samatasvir in the mornings under fasted conditions with water or Coke. Days 5-16: Healthy Volunteers will take omeprazole in the mornings under fasted conditions with water or Coke.
Drug: Samatasvir
Samatasvir 150 mg oral tablets (50mg x 3), single dose

Drug: Omeprazole
40 mg delayed-release oral capsules, once daily




Primary Outcome Measures :
  1. Pharmacokinetic parameter: Area under the concentration-time curve (AUC) from time zero to last measurable concentration [ Time Frame: 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours ]
  2. Pharmacokinetic parameter: AUC from time zero to infinity [ Time Frame: 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours ]
  3. Pharmacokinetic parameter: Maximum observed drug concentration (Cmax) [ Time Frame: 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours ]

Secondary Outcome Measures :
  1. Percentage of participants who experienced at least one serious adverse event [ Time Frame: Up to 17 days ]
  2. Percentage of participants who experienced at least one adverse event [ Time Frame: Up to 17 days ]
  3. Percentage of participants who experienced at least one Grade 1 - 4 laboratory abnormality [ Time Frame: Up to 17 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:

  • Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained.
  • All participants of childbearing potential must agree 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.

Exclusion Criteria:

  • Pregnant or breastfeeding.

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): NCT01813552


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: NCT01813552    
Other Study ID Numbers: 1894-006
IDX-06A-006 ( Other Identifier: Idenix Protocol Number )
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016
Keywords provided by Merck Sharp & Dohme Corp.:
HCV
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
Ritonavir
Omeprazole
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
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors