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Completed

NCT Number: NCT01512693

Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)

This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic insufficiency (abnormal liver function) in order to determine to what degree hepatic dysfunction may impact therapeutic blood levels of MK-0822. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with moderate hepatic insufficiency is similar to that in matched healthy participants following a single 50 mg oral dose.

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Key information

Conditions

Hepatic Insufficiency Digestive System Diseases Liver Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Not currently pregnant, nursing or planning to be pregnant through-out the course of the study; agree to use specified contraception per protocol requirement
  • Body Mass Index (BMI) of ≤ 39 kg/m^2 (not obese)
  • Judged to be in good health (for healthy participant population)
  • Non-smoker for the past 6-months; social smokers (smoke less than 10 cigarettes within the past 3 months; or per discretion of the study Investigator, quit smoking within the past 3 months.
  • Diagnosed with chronic (more than 6 months), stable (no acute episodes of illness within the previous 2 months) hepatic insufficiency (liver dysfunction) with features of cirrhosis due to any cause (for the moderate hepatic insufficiency participant population)
  • Possess the ability to understand the study, grant voluntary informed consent and willingly comply with all study requirements

Exclusion criteria

  • Does not meet the age requirement, is mentally or legally incapacitated, has or is expected to have significant emotional problems, or a history of a clinically significant psychiatric disorder
  • Has been diagnosed with a disease or medical condition which may pose a risk to the participant or may confound the study results
  • Compromised renal (kidney) function, significant organ system disease(s) or cancer(s)
  • Unable to refrain from or anticipates the use of any new medication, including prescription and non-prescription drugs or herbal remedies
  • Meets the requirements of the study in regard to current medication profile including: prescribed medications, caffeine, alcohol, over-the-counter drugs, herbals and nutritional products; with expected non-use of recreational (illicit) drugs associated with misuse, abuse and/or addiction
  • Had surgery, donated 1 unit of blood or received another investigational study medication within 4 weeks prior to the study's first dose of investigational product
  • History of multiple and/or severe allergies, or has had a life-threatening reaction or inability to tolerate prescription or non-prescription drugs or food

Treatment and study plan

MK-0822

Drug

A single oral dose (50 mg tablet) of MK 0822 will be administered on Day 1 after an overnight fast.

Other names: odanacatib

Primary outcomes

  1. Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose

    Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose

    For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.

Secondary outcomes

  1. Maximum Concentration (Cmax) of MK-0822 After Single Dose

    Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose

    For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.

  2. Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose

    Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose

    For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.

  3. Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose

    Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose

    Apparent terminal half-life is the time required to divide the plasma (serum) concentration by two after reaching pseudo-equilibrium. (Note: it is not the time required to eliminate half the administered dose.) For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2. Results are presented using harmonic mean and jackknife standard deviation.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Single Dose Study to Investigate the Pharmacokinetics of Odanacatib (MK-0822) in Subjects With Hepatic Insufficiency

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 19, 2012
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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