Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067)

NCT01512667 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 0822-067
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will investigate and compare pharmacokinetics of a single 50 mg dose of odanacatib administered to participants with impaired renal/kidney function to those of a healthy matched control group. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with impaired renal function is similar to that in matched healthy participants following a single 50 mg oral dose.

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

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

  For healthy and severe renal 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.

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

Secondary Outcomes (3)

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

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

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

  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 (t1/2) of MK-0822 After Single Dose

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

Study Arms (2)

Severe Renal Insufficiency Group

EXPERIMENTAL

Single-dose administration of odanacatib 50 mg to participants with severe renal insufficiency.

Drug: MK-0822

Healthy Matched Control Group

EXPERIMENTAL

Single-dose administration of odanacatib 50 mg to healthy matched control participants.

Drug: MK-0822

Interventions

MK-0822 DRUG

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

Also known as: odanacatib

Healthy Matched Control Group; Severe Renal Insufficiency Group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) of up to 39.49kg/m\^2
• Assessed to be in good health, including no clinically significant cardiac abnormalities based on results from an electrocardiogram (ECG) performed at pre-screening and/or prior to administration of study drug.
• 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.
• Agrees to adhere to all smoking and dietary restrictions associated with the study.
• Possess the ability to understand the study, grant voluntary informed consent, and willingly comply with all study requirements.
• Creatinine clearance of \<30 mL/min
• Creatine clearance of ≥ 90 mL/min (for healthy volunteers)

You may not qualify if:

• Does not meet the age requirement, is mentally or legally incapacitated, has or is expected to have significant emotional problems, and/or a history of a clinically significant psychiatric disorder.
• Diagnosed with a disease or medical condition which may pose a risk to the participant or may confound the study results.
• Has demonstrated or suspected stenosis (narrowing) of the renal artery, and/or has had a renal transplant and/or kidney removal.
• Has current, unstable, significant organ system disease(s) and/or cancer(s).
• Has had a surgical procedure, donated 1 unit of blood or received another investigational study medication within 4 weeks prior to the study's first dose of investigational product.
• Unable to refrain from or anticipates the use of any new medication, including prescription and non-prescription drugs and/or herbal remedies. Exceptions may include medications prescribed for prevention of disease or preservation of a healthy life.
• Uses any medication or agent that has the potential to significantly alter renal/kidney function.
• Unable to avoid taking diuretics (within 4 hours prior to and after dosing with the investigational product) or phosphate binders containing aluminum, calcium or lanthanum salts; iron supplements or other metal cations; antacids; or multivitamins containing iron or zinc (within 8 hours prior to dosing and 4 hours after dosing with the investigational product). Note: individuals prescribed to diuretics must be on a stable dose for at least 4 weeks prior to the study's start date in order to participate.
• History of multiple and/or severe allergies, has had a life-threatening reaction to a drug or other agent, and/or inability to tolerate prescription or nonprescription drugs and/or food.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Renal Insufficiency

Interventions

odanacatib

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 19, 2012
• Study Start: January 17, 2012
• Primary Completion: August 22, 2012
• Study Completion: August 22, 2012
• Last Updated: August 28, 2018
• Results First Posted: February 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share