A Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-1439 (MK-1439-019)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02089659
First received: March 14, 2014
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

This study will investigate the influence of hepatic insufficiency on the pharmacokinetics (PK) of MK-1439. In Part 1, PK of MK-1439 in participants with moderate hepatic insufficiency will be compared with that of healthy control subjects matched with regard to mean age and weight. If a clinically meaningful increase in MK-1439 exposure is observed in participants with moderate hepatic insufficiency in Part 1, study Part 2 will evaluate PK of MK-1439 in participants with mild hepatic insufficiency.


Condition Intervention Phase
HIV-1 Infection
Drug: MK-1439
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 2-Part, Open-Label, Singe-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-1439

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area Under the Plasma Concentration Versus Time Curve from Hour 0 to Infinity (AUC0-infinity) of MK-1439 [ Time Frame: Blood sampling for determination of plasma MK-1439 will be done predose and at 0.5, 1, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours postdose and, for participants with hepatic impairment, at 96, 120, and 144 hours postdose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of MK-1439 [ Time Frame: Blood sampling for determination of plasma MK-1439 will be done at 0.5, 1, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours postdose and, for participants with hepatic impairment, at 96, 120, and 144 hours postdose ] [ Designated as safety issue: No ]
  • Area Under the Plasma Concentration Versus Time Curve from 0 to 24 hours (AUC0-24) of MK-1439 [ Time Frame: Blood sampling for determination of plasma MK-1439 will be done predose and at 0.5, 1, 1.5, 2, 3, 6, 12, and 24 hours postdose ] [ Designated as safety issue: No ]
  • Plasma Concentration of MK-1439 at 24 Hours (C24 hours) [ Time Frame: Blood sampling for determination of plasma MK-1439 will be done at 24 hours postdose ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1: Participants with Moderate Hepatic Insufficiency
A single MK-1439 tablet administered orally with approximately 240 mL water on the morning of Day 1 after an overnight fast. All participants in this arm will have moderate hepatic insufficiency based on the Child-Pugh scale, and at least 4 participants will have a score >=2 on the laboratory parameters of the Child-Pugh scale.
Drug: MK-1439
Active Comparator: Part 1: Healthy Control Participants
A single MK-1439 tablet administered orally with approximately 240 mL water on the morning of Day 1 after an overnight fast
Drug: MK-1439
Experimental: Part 2: Participants with Mild Hepatic Insufficiency
A single MK-1439 tablet administered orally with approximately 240 mL water on the morning of Day 1 after an overnight fast. All participants in this arm will have mild hepatic insufficiency based on the Child-Pugh scale, and at least 4 participants will have a score >=2 on the laboratory parameters of the Child-Pugh scale. This arm will be enrolled and investigated only if a clinically meaningful increase in MK-1439 exposure is observed in participants with moderate hepatic insufficiency in Part 1.
Drug: MK-1439

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) between 19 and 40 kg/m^2
  • Continuous non-smoker or moderate smoker of <20 cigarettes or equivalent per day. Agrees to consume <=10 cigarettes or equivalent per day from the time of screening through the period of sample collection.
  • In good health and with no clinically significant electrocardiogram abnormality
  • Hepatic impairment participants: diagnosis of chronic (>6 months), stable hepatic insufficiency with features of cirrhosis due to any etiology. Part 1 only: score of 7 to 9 on the Child-Pugh scale. Part 2: score of 5 to 6 on the Child-Pugh scale.
  • Females of childbearing potential: sexually inactive for >=14 days before study drug administration and throughout the study, or using 2 acceptable methods of barrier contraception from screening until 14 days after study drug administration.

Exclusion Criteria:

  • Mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the study
  • History or presence of clinically significant medical or psychiatric condition or disease
  • History or presence of drug abuse within the past 2 years
  • History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds
  • Female participant who is pregnant or lactating
  • Positive results for breath alcohol or urine drug screen (unless due to prescription drug use and is approved by the investigator) at screening
  • Positive for HIV at screening
  • Unable to refrain from or anticipates the use of any drug known to be a significant inhibitor or inducer of cytochrome oxidase CYP3A or P-glycoprotein, or any medication or substance which cannot be discontinued at least 14 days before study drug administration and throughout the study.
  • Donation of >500 mL of blood or had significant blood loss within 56 days before study drug administration
  • Plasma donation within 7 days before study drug administration
  • Dosed in another clinical trial within 28 days before study drug administration
  • Healthy control participants only: positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) at screening;
  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: NCT02089659

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, Florida
Call for Information (Investigational Site 0001) Recruiting
Hialeah, Florida, United States, 33014
Call for Information (Investigational Site 0002) Recruiting
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02089659     History of Changes
Other Study ID Numbers: 1439-019
Study First Received: March 14, 2014
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatic Insufficiency
HIV Infections
Liver Diseases
Digestive System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014