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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335607
• Other study ID #: 2355-006
• Secondary ID: IDX-08C-006
• Status: Completed
• Phase: Phase 1
• First received: April 8, 2011
• Last updated: January 25, 2016
• Start date: April 2011
• Est. completion date: May 2011

Study information

• Verified date: January 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• Samatasvir tablet
Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose)
• Samatasvir capsule
Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Pharmacokinetic parameter: Plasma concentration at 24 hours post dose (C24h)		24 hours	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Percentage of participants who experienced an adverse event		Up to Day 20	Yes
Secondary	Percentage of participants who experienced a serious adverse event		Up to Day 20	Yes
Secondary	Percentage of participants who experienced a Grade 1-4 laboratory abnormality		Up to Day 20	Yes