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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01335607
First received: April 8, 2011
Last updated: February 4, 2015
Last verified: February 2015
  Purpose

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.

Condition Intervention Phase
Hepatitis C
Drug: Samatasvir tablet
Drug: Samatasvir capsule
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase I, Open-label Study to Evaluate the Relative Bioavailability of IDX184 and Food Effect in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter: Plasma concentration at 24 hours post dose (C24h) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of participants who experienced an adverse event [ Time Frame: Up to Day 20 ] [ Designated as safety issue: Yes ]
  • Percentage of participants who experienced a serious adverse event [ Time Frame: Up to Day 20 ] [ Designated as safety issue: Yes ]
  • Percentage of participants who experienced a Grade 1-4 laboratory abnormality [ Time Frame: Up to Day 20 ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: April 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Part A: Samatasvir cap→tab→tab; Part B: cap
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
Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose)
Drug: Samatasvir capsule
Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)
Active Comparator: Part A: Samatasvir tab→cap→tab; Part B: cap
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
Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose)
Drug: Samatasvir capsule
Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335607

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01335607     History of Changes
Other Study ID Numbers: 2355-006, IDX-08C-006
Study First Received: April 8, 2011
Last Updated: February 4, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
HCV
Hepatitis C Virus

Additional relevant MeSH terms:
Hepatitis C
Digestive System Diseases
Flaviviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 01, 2015