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

NCT01335607 | Completed Phase 1

• 2 other identifiers: 2355-006IDX-08C-006
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatitis C

Keywords

HCV; Hepatitis C Virus

Outcome Measures

Primary Outcomes (9)

• Pharmacokinetic parameter: Observed maximum plasma drug concentration (Cmax)

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

• Pharmacokinetic parameter: Time to maximum concentration (Tmax)

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

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

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

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

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

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

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

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

  24 hours

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

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

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

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

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

  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 (3)

• Percentage of participants who experienced an adverse event

  Up to Day 20

• Percentage of participants who experienced a serious adverse event

  Up to Day 20

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

  Up to Day 20

Study Arms (2)

Part A: Samatasvir cap→tab→tab; Part B: cap

ACTIVE COMPARATOR

Part A: Samatasvir capsule as a single dose on Day 1 (fasting state) followed by samatasvir tablet as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state)

Drug: Samatasvir tablet; Drug: Samatasvir capsule

Part A: Samatasvir tab→cap→tab; Part B: cap

ACTIVE COMPARATOR

Part A: Samatasvir tablet as a single dose on Day 1 (fasting state) followed by samatasvir capsule as a single dose on Day 8 (fasting state) followed by samatasvir tablet as a single dose on Day 15 (fed state); Part B: samatasvir capsule as a single dose on Day 1 (fed state)

Drug: Samatasvir tablet; Drug: Samatasvir capsule

Interventions

Samatasvir tablet DRUG

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

Part A: Samatasvir cap→tab→tab; Part B: cap; Part A: Samatasvir tab→cap→tab; Part B: cap

Samatasvir capsule DRUG

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

Part A: Samatasvir cap→tab→tab; Part B: cap; Part A: Samatasvir tab→cap→tab; Part B: cap

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

samatasvir

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 14, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 26, 2016

Record last verified: 2016-01