Is NCT06442436 recruiting in Orlando, FL?

Yes, NCT06442436 is currently recruiting participants at its Orlando, FL location. This hepatic impairment (hi) clinical trial is actively enrolling qualified participants.

How do I join the hepatic impairment (hi) clinical trial in Orlando?

To join this clinical trial in Orlando, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Orlando clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Hepatic Impairment (HI) Clinical Trial in Orlando, FL

About This Hepatic Impairment (HI) Study in Orlando

The purpose of this study is to compare the plasma pharmacokinetics (PK) of nemtabrutinib (MK-1026) following a single oral dose of nemtabrutinib in participants with moderate hepatic impairment to that of healthy matched control participants and to evaluate the safety and tolerability of nemtabrutinib.

Sponsor: Merck Sharp & Dohme LLC

Who Can Participate

Inclusion Criteria

Has a body mass index (BMI) between 18.0 and 40.0 kg/m2, inclusive.

Is assigned male or female sex at birth. Participants assigned female sex at birth must not be pregnant or breast feeding and must be of nonchild bearing potential.

Who agrees to use contraception.

Has provided documented informed consent for the study.

Has a diagnosis of chronic (\>6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic impairment with features of cirrhosis due to any etiology (moderate HI only).

Has moderate hepatic impairment (class B) by the Child-Pugh classification system AND/OR the participant has moderate impairment by the National Cancer Institution Organ Dysfunction Working Group (NCI-ODWG) classification system (moderate HI only).

Is in general good health (except for Moderate HI).

Exclusion Criteria

Has a clinically significant condition that may affect absorption of the study drug in the opinion of the investigator, including gastric restrictions and bariatric surgery (eg, gastric bypass).

Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years.

Has a history of cancer (malignancy).

Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (systemic allergic reaction) to prescription or nonprescription drugs or food.

Had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy.

Has received any vaccine starting from 14 days prior to study or is scheduled to receive any vaccine through 30 days following study intervention.

Was dosed in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to check-in (Day -1).

Is under the age of consent.

Is heavy smoker or heavy user of nicotine-containing products (\>20 cigarettes or equivalent/day).

Is regular user of cannabis or any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months.

Consumes greater than 3 servings of alcoholic beverages per day.

Consumes excessive amounts, defined as greater than 6 servings of coffee, tea, cola, (1 serving is approximately equivalent to 120 mg of caffeine) energy drinks, or other caffeinated beverages per day.

Is unwilling to comply with the study restrictions.

Has a history or illness that in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study (moderate HI only).

Has a history of recent variceal bleeds (for moderate HI only).

Has evidence of hepatorenal syndrome (for moderate HI only).

Has fluctuating or rapidly deteriorating hepatic function within the prestudy period, in the opinion of the investigator (for moderate HI only).

Is not in sufficient health, with regard to stability of HI, to undergo participation in the study with anticipated survival of \<3 months, in keeping with a Model for End-Stage Liver Disease (MELD) score of ≥25 (for moderate HI only).

Has a history of liver or other solid organ transplantation (for moderate HI only).

Has an active infection requiring systemic therapy (for moderate HI only).

Who requires paracentesis more often than 2 times per month (for moderate HI only).

Has a transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting (for moderate HI only).

Has encephalopathy Grade 3 or worse within 28 days before administration of study intervention (for moderate HI only).

Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start (for moderate HI only).

Is positive for human immunodeficiency virus (HIV)-1 or HIV-2 or using HIV protease inhibitors (for moderate HI only).

Is positive for HBV (for moderate HI only).

Is positive for HCV (for moderate HI only).

Is taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medication(s) for the prohibited period of time in study (for moderate HI only).

Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological (history of a bleeding disorder, abnormal bleeding or a hereditary or acquired coagulation or platelet disorder), hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke, intracranial hemorrhage, and chronic seizures) abnormalities or diseases (for healthy control participants only).

Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV at the prestudy (screening) visit (for healthy control participants only).

Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies (for healthy control participants only).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orlando?

Yes, this clinical trial (NCT06442436) has an active research site in Orlando, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hepatic Impairment (HI) Treatment Options in Orlando, FL

If you're searching for hepatic impairment (hi) treatment options in Orlando, FL, this clinical trial (NCT06442436) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orlando research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hepatic impairment (hi) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hepatic impairment (hi) clinical trials near you to find additional studies recruiting in your area.

Hepatic Impairment (HI) Clinical Trial in Orlando, FL

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