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Completed

NCT Number: NCT01335607

A Open-label Study to Evaluate the Relative Bioavailability of Samatasvir (IDX184) and Food Effect in Healthy Male Participants (MK-2355-006)

The purpose of this study is to:

* Assess the relative bioavailability of 2 oral formulations of samatasvir (capsule and tablet prototype test formulation) * Compare the amount of study drug that is in the blood after taking either the capsule form of the drug or the tablet form of the drug while fasting. * Determine the amount of study drug that is in the blood after eating a meal. * Evaluate the safety of the tablet form of samatasvir in healthy people.

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Key information

Conditions

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

Age range

19 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

Each participant will receive each of the formulations in a crossover design. Part A Periods 1 and 2: Participants will receive either samatasvir capsules or tablets according to randomization under fasting conditions on Days 1 and 8. Part A Period 3: All participants will receive samatasvir tablets under fed conditons on Day 15.

Each dose will be separated by a 7-day wash-out period. Part B: All participants will receive samatasvir capsules under fed conditons on Day 1.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must be a healthy male with body mass index (BMI) between 18 and 35 kg/m
  • Must agree to use an acceptable double-barrier method of birth control.
  • Must provide written informed consent after the study has been fully explained.

Exclusion criteria

  • History of clinically significant diseases, as determined by the investigator.
  • Safety laboratory abnormalities at screening which are clinically significant.
  • Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
  • Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study.
  • Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.

Treatment and study plan

Samatasvir tablet

Drug

Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose)

Samatasvir capsule

Drug

Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)

Primary outcomes

  1. Pharmacokinetic parameter: Observed maximum plasma drug concentration (Cmax)

    Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours

  2. Pharmacokinetic parameter: Time to maximum concentration (Tmax)

    Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours

  3. Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to last measurable concentration (AUC 0-t)

    Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours

  4. Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to 24 hours (AUC 0-24)

    Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours

  5. Pharmacokinetic parameter: Area under the drug concentration-time curve from time 0 to infinity (AUC 0-infinity)

    Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours

  6. Pharmacokinetic parameter: Plasma concentration at 24 hours post dose (C24h)

    Time frame: 24 hours

  7. Pharmacokinetic parameter: Observed plasma terminal half-life (T1/2)

    Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours

  8. Pharmacokinetic parameter: Apparent oral total plasma clearance (CL/F)

    Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours

  9. Pharmacokinetic parameter: Apparent oral total plasma volume of distribution (Vz/F)

    Time frame: Predose (0 hours) and postdose at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours

Secondary outcomes

  1. Percentage of participants who experienced an adverse event

    Time frame: Up to Day 20

  2. Percentage of participants who experienced a serious adverse event

    Time frame: Up to Day 20

  3. Percentage of participants who experienced a Grade 1-4 laboratory abnormality

    Time frame: Up to Day 20

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase I, Open-label Study to Evaluate the Relative Bioavailability of IDX184 and Food Effect in Healthy Male Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 14, 2011
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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