A Single-Dose Study of the Pharmacokinetics of MK-4618 in Patients With Hepatic Insufficiency (MK-4618-013)



Status:Completed
Conditions:Overactive Bladder, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:5/27/2013
Start Date:January 2013
End Date:May 2013
Contact:Toll Free Number
Phone:1-888-577-8839

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A Two-Part, Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4618 in Patients With Hepatic Insufficiency


This study will investigate the pharmacokinetics of a single oral dose of MK-4618
administered to participants with moderate hepatic insufficiency and healthy participants
matched for age, gender, and body mass index (BMI). Participants may be enrolled with mild
hepatic insufficiency.


This study is planned to be conducted in two parts. Part 1 of the study will include
participants with moderate hepatic insufficiency and healthy participants. If Part 2 is
conducted, Part 2 of the study will include participants with mild hepatic insufficiency.

Inclusion Criteria

For both healthy participants and participants with hepatic insufficiency:

- Continuous non-smokers who haven't used nicotine-containing products for at least 3
months prior to study drug administration

- Body mass index (BMI) ≤39 kg/m^2

- Good health based on medical history, physical examination, vital signs, laboratory
safety tests, and electrocardiogram (ECG)

- Females of childbearing potential must be sexually inactive for 14 days prior to
study drug administration and throughout study or use acceptable birth control method

- Females of non-childbearing potential must have undergone an acceptable sterilization
procedure at least 6 months prior to Day 1 of study or be postmenopausal with
amenorrhea for at least 1 year prior to Day 1

- Non-vasectomized males must agree to use a condom with spermicide or abstain from
sexual intercourse during the trial and for 3 months after study drug administration

For participants with hepatic insufficiency only:

- Diagnosis of chronic, stable, hepatic insufficiency

- For Part 1 Participants: Child-Pugh scale range from 7 to 9

- For Part 2 Participants: Child-Pugh scale range from 5 to 6

Exclusion Criteria

- History or presence of significant cardiovascular, pulmonary, renal, hematologic,
gastrointestinal, endocrine, immunologic, dermatologic, neurological disease

- History or presence of alcoholism or drug abuse within the past 2 years

- Females who are pregnant or lactating

- Use of any drugs or substances known to be significant inhibitors or inducers of
cytochrome P3A (CYP3A) enzymes and/or permeability glycoprotein (P-gp)
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