Skip to main content
OpenTrials
Completed

NCT Number: NCT01813552

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Hepatitis C Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Samatasvir

Drug

Samatasvir 150 mg oral tablets (50mg x 3), single dose

Omeprazole

Drug

40 mg delayed-release oral capsules, once daily

Ritonavir

Drug

100 mg oral tablets, once daily

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase I, Randomized, Open-label Study to Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of IDX719 in Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2013
Registry last updated
Jan 22, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.