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Completed

NCT Number: NCT01813513

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

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.

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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

18 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

  • 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

Treatment and study plan

IDX719

Drug

50 mg tablet for oral administration

Other names: Samatasvir

Simeprevir

Drug

150 mg capsule for oral administration

Other names: Olysio™

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2013
Registry last updated
Jan 26, 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.

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