A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Participants With Impaired Renal Function (MK-7655-005)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-28

Study Completion Date

2012-03-05

Brief Summary

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This is a 2-part study of the pharmacokinetics (PK) of MK-7655. In Part I, the PK of a single 125 mg dose of MK-7655 given in combination with 250 mg of PRIMAXIN® (imipenem + cilastatin) will be determined in participants with impaired renal function and matched control participants. In Part II, the potential for renal insufficiency to affect non-renal clearance mechanisms will be investigated.

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Detailed Description

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Conditions

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Infectious Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Panel A Mild Renal Impairment

Participants with an eGFR of \>50 to \<80 mL/min/1.73 m\^2 receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.

Group Type EXPERIMENTAL

MK-7655

Intervention Type DRUG

125 mg intravenous (IV) over 30 minutes as a single dose

Imipenem + Cilastatin

Intervention Type DRUG

250 mg IV over 30 minutes as a single dose

Panel B Healthy Participants

A subset of healthy control participants were matched specifically to participants in Panel A and receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.

Group Type EXPERIMENTAL

MK-7655

Intervention Type DRUG

125 mg intravenous (IV) over 30 minutes as a single dose

Imipenem + Cilastatin

Intervention Type DRUG

250 mg IV over 30 minutes as a single dose

Panel C Moderate Renal Impairment

Participants with an eGFR of 30 to 50 mL/min/1.73 m\^2 receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.

Group Type EXPERIMENTAL

MK-7655

Intervention Type DRUG

125 mg intravenous (IV) over 30 minutes as a single dose

Imipenem + Cilastatin

Intervention Type DRUG

250 mg IV over 30 minutes as a single dose

Panel D Healthy Participants

A subset of healthy control participants were matched specifically to participants in Panel C and receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1.

Group Type EXPERIMENTAL

MK-7655

Intervention Type DRUG

125 mg intravenous (IV) over 30 minutes as a single dose

Imipenem + Cilastatin

Intervention Type DRUG

250 mg IV over 30 minutes as a single dose

Panel E Severe Renal Impairment

Participants with an eGFR \<30 mL/min/1.73 m\^2 receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.

Group Type EXPERIMENTAL

MK-7655

Intervention Type DRUG

125 mg intravenous (IV) over 30 minutes as a single dose

Imipenem + Cilastatin

Intervention Type DRUG

250 mg IV over 30 minutes as a single dose

Caffeine

Intervention Type DRUG

Caffeine caplet, single 200 mg dose, orally

Midazolam

Intervention Type DRUG

Midazolam hcl syrup single 2.0 mg dose by mouth.

Omeprazole

Intervention Type DRUG

Omeprazole tablets, single 40 mg dose (as two 20 mg tablets), orally

Panel F Healthy Participants

A subset of healthy control participants were matched specifically to participants in Panel E and receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.

Group Type EXPERIMENTAL

MK-7655

Intervention Type DRUG

125 mg intravenous (IV) over 30 minutes as a single dose

Imipenem + Cilastatin

Intervention Type DRUG

250 mg IV over 30 minutes as a single dose

Caffeine

Intervention Type DRUG

Caffeine caplet, single 200 mg dose, orally

Midazolam

Intervention Type DRUG

Midazolam hcl syrup single 2.0 mg dose by mouth.

Omeprazole

Intervention Type DRUG

Omeprazole tablets, single 40 mg dose (as two 20 mg tablets), orally

Panel G End Stage Renal Disease with Hemodialysis (ESRD/HD)

Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2). In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg predialysis (Part 2, Period 1) and postdialysis (Part 2, Period 2).

Group Type EXPERIMENTAL

MK-7655

Intervention Type DRUG

125 mg intravenous (IV) over 30 minutes as a single dose

Imipenem + Cilastatin

Intervention Type DRUG

250 mg IV over 30 minutes as a single dose

Caffeine

Intervention Type DRUG

Caffeine caplet, single 200 mg dose, orally

Midazolam

Intervention Type DRUG

Midazolam hcl syrup single 2.0 mg dose by mouth.

Omeprazole

Intervention Type DRUG

Omeprazole tablets, single 40 mg dose (as two 20 mg tablets), orally

Panel H Healthy Volunteers

A subset of healthy control participants were matched specifically to participants in Panel G and receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.

Group Type EXPERIMENTAL

MK-7655

Intervention Type DRUG

125 mg intravenous (IV) over 30 minutes as a single dose

Imipenem + Cilastatin

Intervention Type DRUG

250 mg IV over 30 minutes as a single dose

Caffeine

Intervention Type DRUG

Caffeine caplet, single 200 mg dose, orally

Midazolam

Intervention Type DRUG

Midazolam hcl syrup single 2.0 mg dose by mouth.

Omeprazole

Intervention Type DRUG

Omeprazole tablets, single 40 mg dose (as two 20 mg tablets), orally

Interventions

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MK-7655

125 mg intravenous (IV) over 30 minutes as a single dose

Intervention Type DRUG

Imipenem + Cilastatin

250 mg IV over 30 minutes as a single dose

Intervention Type DRUG

Caffeine

Caffeine caplet, single 200 mg dose, orally

Intervention Type DRUG

Midazolam

Midazolam hcl syrup single 2.0 mg dose by mouth.

Intervention Type DRUG

Omeprazole

Omeprazole tablets, single 40 mg dose (as two 20 mg tablets), orally

Intervention Type DRUG

Other Intervention Names

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RELEBACTAM® PRIMAXIN® No Doz® VERSED® PRILOSEC®

Eligibility Criteria

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Inclusion Criteria

* Participants of reproductive potential (male or female) must be willing to use contraception.
* Body Mass Index (BMI) ≤40 kg/m\^2
* Weight \>60 kg at screening visit
* No clinically significant abnormality on electrocardiogram (ECG) at screening visit and/or prior to administration of the initial dose of study drug
* Panels A-D: smokers will be limited to no more that 10 cigarettes per day.
* Panels E-H: nonsmoker or has not used nicotine for at least 6 months
* In good health (stable health for participants with renal impairment)

Exclusion Criteria

* Pregnant or breastfeeding.
* History of recent stroke, chronic seizures, or major neurological disorder
* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, respiratory, or genitourinary abnormalities or diseases
* History of malignant neoplastic disease. Exceptions: (1) adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix; (2) other malignancies that have been successfully treated ≥10 years prior to the screening visit
* Panels A-D: Use of any medication (prescription or non-prescription) or herbal remedies (such as St. John's Wort \[Hypericum perforatum\]) beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug to the post study visit
* Panels E-H: Use of any medication (prescription or non-prescription) or herbal remedies (such as St. John's Wort \[Hypericum perforatum\]) that are inhibitors or inducers of CYP1A2, CYP2C19, CYP34A, or substrates of CYP2C19, beginning approximately 2 weeks (or 5 half-lives) prior to administration of the probe cocktail, until the post-study visit
* Consumption of greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer \[284 mL/10 ounces\], wine \[125 mL/4 ounces\], or distilled spirits \[25 mL/1 ounce\]) per day
* Consumption of greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
* Major surgery, donation or loss of 1 unit of blood (approximately 500 mL), or participation in another investigational study within 4 weeks prior to the screening visit
* History of multiple and/or severe allergies (including latex allergy), or prior anaphylactic reaction or intolerability to prescription or non-prescription drugs or food
* History of hypersensitivity to PRIMAXIN® IV or other beta lactam antibiotic (including but not limited to penicillins, cephalosporins, monobactams and carbapenems)
* Regular user (including recreational use of drugs \[including alcohol\]) within approximately 12 months of screening visit
* History of kidney removal and/or renal transplant
* History of Clostridium difficile colitis or known C. difficile colonization

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes