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Completed

NCT Number: NCT01907724

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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms 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

  • 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)

Treatment and study plan

IDX719

Drug

IDX719 will be supplied as a 50 mg tablet for oral administration.

Simeprevir

Drug

Simeprevir will be supplied as 75 mg capsules for oral administration.

Other names: Olysio™

TMC647055

Drug

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

RTV

Drug

RTV will be supplied as 80 mg/mL solution for oral administration.

Other names: Norvir™

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 25, 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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